Medical device manufacturer, Diatron, has issued a medical device safety alert concerning its M2400 Reaction Cuvette for Pictus analyzers [Catalogue Number: 10022998, 10022999, 10123263; multiple batch numbers manufactured from 2017-09-01; only the cuvettes are affected that were manufactured from Cavity 'G']. The potentially affected products are reusable cuvettes (M2400 Cuvette) intended to be used on Pictus 200 (P200), Pictus 400 (P400), Pictus 500 (P500), Pictus 700 (P700) analyzers.
During the internal quality control process, the manufacturer has observed that due to a manufacturing defect, micro-holes may occur on the bottom or on the side of the reaction cuvettes. The defect affects always the same single cuvette on a 5-cuvettes strip. The defect occurs randomly at a low rate, but when it appears it is consecutive for a number of pieces.
According to the manufacturer, the different reagents may leak differently depending on their individual physicochemical characteristics and the size of the micro-hole, and it may affect the measurement results. The manufacturer also observed that depending on the size of the hole, liquid may leak from the cuvette inside the instrument during the washing process. This may cause the instrument malfunction or stop. The defect is always found on the same single 5th cuvette on a 5-cuvettes strip. Usually, when the defect appears, it affects the whole box of cuvettes. After the system is loaded with a new set of cuvettes, the device automatically checks all the new cuvettes before starting the measurement. The instrument scans for faulty cuvettes and excludes them from the measurements. It was found that some cuvettes were not rejected by the instrument and those were accepted for tests due to the unique technical characteristics of an instrument (experienced rejection rate is 85%).
The internal studies show probability of false results - depending on individual physical-chemical characteristics of the used reagents - if a test is performed in a defective cuvette that was not voided by the instrument. The instrument scan data trends suggest that the Pictus analyzers will void leaking and contaminated cuvettes after 3-4 uses. Once voided by the analyzers, the cuvettes are blocked from use and thus the risks of further reporting wrong results are null. The internal review of all complaints from the field over the last three years showed no incident of any false patient result, which is related to such a cuvette defect.
Product removal and destroy are on-going.
According to the manufacturer, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 September 2020