BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2572201 · Received May 14, 2012

    Report

    Report Number
    9610824-2012-00069
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Date of Event
    April 16, 2012
    Report Date
    May 14, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CELL #1 OF BIOTESTCELL 3 YIELDED FALSE POSITIVE ANTIBODY SCREENING TEST RESULTS IN THE ORTHO GEL SYSTEM. THE CUSTOMER SAID THAT THIS WAS AN ONGOING PROBLEM, BUT SHE WAS NOT ABLE TO PROVIDE THE PRECISE DATE WHEN THE PROBLEM OCCURED. THE LAST OCCURRENCE WAS ON OUR STATED DATE OF EVENT, ON (B)(6) 2012. THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE RESULT WAS SENT TO US FOR QUALITY CONTROL AND THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED, TOO. OUR QUALITY CONTROL LABORATORY RETESTED THE ALLEGEDLY DEFECTIVE SAMPLE OF BIOTESTCELL 3 WITH THE PATIENT SAMPLES IN SOLIDSCREEN II ON TANGO AND IN THE 3- PHASE TUBE TECHNIQUE. ONLY ONE OF THE TWO PATIENT SAMPLES, SAMPLE #1, YIELDED A WEAK POSITIVE REACTION IN THE INDIRECT ANTIHUMAN GLOBULIN TEST IN TUBE WITH CELL #1 OF BIOTESTCELL #1. FURTHERMORE, PATIENT SAMPLE #1 WAS TESTED IN TUBE TECHNIQUE WITH AN INCUBATION AT 4°C IN COLD. PATIENT SAMPLE #1 REACTED WITH ALL THREE SCREENING CELLS WEAK POSITIVELY. THE RETAINED SAMPLE OF BIOTESTCELL 3 WAS TESTED WITH DIFFERENT POSITIVE AND NEGATIVE SAMPLES ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. THE GEL CARD SYSTEM IS NOT SUITABLE FOR THE CUSTOMER´S INTENDED APPLICATION: DETECTION OF UNEXPECTED ANTIBODIES. IN THIS CASE, WE RECOMMEND THE TUBE TEST OR SOLID PHASE TEST SOLIDSCREEN II WITH TANGO OPTIMO. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 3 FUNCTIONS CORRECTLY. THE POSITIVE REACTION OF PATIENT SAMPLE #1 WAS CAUSED BY AN COLD REACTING ANTIBODY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8211021

    Patients

    Seq Age Sex Outcome Treatment
    1 ORTHO GEL PANEL: LOT RC393