BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM

    MDR report key: 4825172 · Received June 8, 2015

    Report

    Report Number
    1823260-2015-03592
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 17, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DDG
    PMA / PMN Number
    K003064
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE DETERMINED THAT THERE IS AN IMPRECISION WITH REAGENT LOT 606449. RETENTION TESTING OF THE LOT HAS SHOWN THAT PRECISION IS OUTSIDE OF SPECIFICATIONS. THE ROOT CAUSE OF THE REAGENT LOT IMPRECISION IS NOT KNOWN. THE REAGENT LOT WAS CHANGED AT THE CUSTOMER SITE AND NO FURTHER ISSUES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR A TOTAL OF TEN PATIENT SAMPLES TESTED FOR TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR (STFR). OF THE TEN SAMPLES, NINE WERE FOUND TO HAVE ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER INITIALLY RECEIVED A DATA ALARM WITH ONE PATIENT SAMPLE RESULT. THE REACTION CURVE FOR THE RESULT WAS NOTED TO BE "JUMPY" AND NOT NORMAL. ALL OTHER RESULTS FROM THAT SAME DAY WERE THEN CHECKED AND 9 ADDITIONAL SAMPLES WERE NOTED TO HAVE "JUMPY" REACTION CURVES. THESE 9 SAMPLE RESULTS WERE NOT ACCOMPANIED BY ALARMS. THE SAMPLES WERE REPEATED AND RESULTS WERE DIFFERENT. THE FIRST RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. AFTER NOTICING THE ISSUE, THE LABORATORY COMMUNICATED THAT THERE WERE FAULTY RESULTS AND THE REPEAT RESULTS WERE THEN REPORTED OUTSIDE OF THE LABORATORY. THE REACTION CURVES OF OTHER ANALYTES APPEARED TO BE OK AND THESE WERE NOT RETESTED. CONTROL RESULTS WERE STATED TO BE OK ON THE MORNING OF (B)(6) 2015. AFTER THE FIRST PATIENT RESULTS WERE GENERATED, ONE CONTROL LEVEL WAS ANALYZED AND FOUND TO BE OUT OF RANGE. ALL CONTROLS WERE THEN ANALYZED APPROXIMATELY 3 HOURS LATER AND ALL WERE WITHIN RANGE. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE STFR REAGENT LOT NUMBER WAS 606449. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. IT WAS DETERMINED THAT THE LAST CALIBRATION OF THE ASSAY WAS PERFORMED ON 05/13/2015. ACCORDING TO PRODUCT LABELING, CALIBRATION MUST BE PERFORMED EVERY 6 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367588 TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL DDG ROCHE DIAGNOSTICS NA 606449

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR