BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERKINELMER GENETIC SCREENING PROCESSOR (GPS)

    MDR report key: 2651950 · Received July 9, 2012

    Report

    Report Number
    8043909-2012-00001
    Event Type
    Other
    Date Received
    July 9, 2012
    Date of Event
    May 15, 2012
    Report Date
    July 9, 2012
    Manufacturer
    PERKINELMER WALLAC, OY.
    Product Code
    JLW
    PMA / PMN Number
    K090846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS INVESTIGATED BY WALLAC AND THE YELLOWISH SOLUTION IN THE WELLS WAS FOUND TO BE DUE TO CONTAMINATION BY METAL COMPOSITED FROM THE STAINLESS STEEL. THE SOURCE OF THIS PROBLEM WAS IDENTIFIED AS THE SHAKER UNIT OF THE GSP INSTRUMENT. OVER THE COURSE OF TIME, DUE TO CONTACT WITH THE ACIDIC INDUCER SOLUTION, A WHITE RESIDUE MAY ACCUMULATE UNDERNEATH METAL SURFACE OF THE SHAKER (INCUBATOR) SHELVES. THIS WHITE ACIDIC RESIDUE CAUSES CORROSION AND IN THE PRESENCE OF METAL CHANGES TO A DARK SUBSTANCE THAT ACCUMULATES ON THE SHAKER SHELVES. IT HAS BEEN DETERMINED THAT THIS DARK SUBSTANCE CONTAINS IRON. IRON IS KNOWN TO CAUSE QUENCHING OF THE TIME-RESOLVED FLUORESCENCE SIGNAL USED TO MEASURE THE IRT CONCENTRATION IN THE GSP NEONATAL IRT ASSAY. PERKINELMER INITIATED RECALL ACTIVITIES WITH THE CUSTOMERS ON 06/27/2012. THE RECALL WAS REPORTED TO FDA JUNE 21, 2012. AS AN INTERIM CORRECTIVE ACTION ALL THE SHAKER UNITS OF THE INSTRUMENTS WILL BE INSPECTED AND CLEANED BY SERVICE TECHNICIANS. THIS CLEANING WILL BE REPEATED ON A MONTHLY BASIS UNTIL THE FINAL CORRECTIVE ACTION IS IMPLEMENTED. AS A FINAL CORRECTIVE ACTION PERKINELMER WILL REPLACE ALL THE SHAKERS IN ALL GSP INSTRUMENTS WITH NEW SHAKERS MANUFACTURED USING AN ACID RESISTANT STEEL.

    Description of Event or Problem · 1

    THE PERKINELMER GSP NEONATAL IRT ASSAY IS USED FOR NEWBORN SCREENING (NBS) OF CYSTIC FIBROSIS (CF) IN (B)(6). DURING ROUTINE NBS ON (B)(6) 2012, THE LAB NOTICED ON ONE MICROTITRATION PLATE 7 WELLS WITH YELLOWISH SOLUTION THAT PRODUCED VERY LOW IRT (IMMUNO-REACTIVE TRYPSIN) RESULTS. ALL OF THE 7 SPECIMENS WERE RETESTED AND ONE OF THE SPECIMENS GAVE A SIGNIFICANTLY HIGHER IRT RESULT DURING RETESTING, INDICATING A POSITIVE CF RESULT. THE OTHER 6 REPEATED SPECIMENS REMAINED NEGATIVE AFTER SPECIMEN RETESTING. THE CONFIRMATORY TESTING WAS PERFORMED FOR THE SCREEN POSITIVE CG RESULT PT USING MOLECULAR ANALYSIS AND A HETEROZYGOTE DELETION OF F508 WAS DIAGNOSED. THE FALSE NEGATIVE SCREENING RESULT WAS REPORTED AS A CUSTOMER COMPLAINT TO PERKINELMER ON (B)(4) 2012. AT THE TIME OF THIS REPORT, PERKINELMER HAS NOT RECEIVED ANY FURTHER INFO ABOUT THE BABY'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERKINELMER GENETIC SCREENING PROCESSOR (GPS) FLUOROMETER FOR CLINICAL USE JLW PERKINELMER WALLAC, OY. 2010-0010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other