BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    MDR report key: 3081994 · Received April 29, 2013

    Report

    Report Number
    9610824-2013-00040
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MULTIPLE TANGO OPTIMO USERS MISSED AN ANTI-C OF A PROFIENCY TEST WITH BIOTESTCELL 1 AND 2. THE EXACT DATE OF EVENT IS UNKNOWN. THE CUSTOMER HAS NEITHER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PROFICIENCY SURVEY SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE A TESTING OF THE RETAINED SAMPLE WAS NOT POSSIBLE. 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
    184645 REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 BIOTESTCELL 1&2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8303021-00

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL POOL, LOT 8303011-00, EXP. 03/05/2013| BIOTESTCELL POOL, LOT 8307011-00, EXP. 04/02/2013