BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTESTCELL 3

    MDR report key: 2527074 · Received September 1, 2009

    Report

    Report Number
    9610824-2009-00005
    Event Type
    Malfunction
    Date Received
    September 1, 2009
    Date of Event
    July 27, 2009
    Report Date
    September 1, 2009
    Manufacturer
    BIOTEST MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: THE CUSTOMER COULD SEND US NEITHER THE COMPLAINT BIOTESTCELL 3 NOR THE MISSED ANTIBODIES. THE RETENTION SAMPLE OF THE AFFECTED LOT BIOTESTCELL 3 COULD BE TESTED AFTER EXCEEDING THE EXPIRY DATE. THIS TESTING WAS PERFORMED WITH AN ANTI-D STANDARD OF IMMUCOR. THE TESTING FULFILLED THE RECOMMENDATIONS OF IMMUCOR. THEREFORE, THE ANTIGENICITY OF THE D ANTIGEN EVEN AFTER EXCEEDING THE EXPIRY DATE WAS PROVED. THE THREE MISSED ANTIBODIES AND THE AFFECTED REAGENT RED BLOOD CELLS WERE USED ONE DAY BEFORE EXPIRY DATE. THERE IS A HINT IN OUR INSTRUCTION FOR USE THAT "THE REACTIVITY OF THE PRODUCT MAY DECREASE DURING THE DATING PERIOD AND, THEREFORE, SHOULD NOT BE USED AFTER THE EXPIRATION DATE. THE RATE OF DECREASE IN REACTIVITY IS PARTIALLY DEPENDANT ON INDIVIDUAL DONOR CHARACTERISTICS THAT ARE NEITHER CONTROLLED NOR PREDICTED BY THE MANUFACTURER." OUR TESTS IN THE QUALITY CONTROL LABORATORIUM CONFIRMED THE CORRECT FUNCTION OF THE BIOTESTCELL 3. BECAUSE THE SAMPLES OF CUSTOMER COULDN'T BE TESTED AT QUALITY CONTROL LABORATORY EVEN A PROBLEM OF HANDLING AT CUSTOMER'S SIDE CAN NOT BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT HE MISSED THREE ANTIBODIES (ONE ANTI-D, ONE ANTI-E AND ONE ANTI-LE(A)) WITH BIOTESTCELL 3, ART-NO. 816085100, LOT 7924011. THE CUSTOMER PERFORMED TESTING WITH THE AFFECTED BIOTESTCELL 3 ONE DAY BEFORE EXPIRATION DATE OF THE TEST CELLS. WHEN THE CUSTOMER REPEATED THE TESTING THE NEXT DAY WITH THE NEW LOT OF BIOTESTCELL 3 ALL THREE ANTIBODIES REACTED CORRECT POSITIVE. THE REPORTED REACTIONS STRENGTHS (W(WEAK) + TILL 2 + REACTIONS) SHOW THAT THERE WERE WEAK POSITIVE REACTING ANTIBODIES. THE MAXIMUM REACTION STRENGTH IS 4+. THE METHOD OF CUSTOMER TESTING WAS THE ORTHO GELSYSTEM. WHEN THE COMPLAINT WAS REPORTED, THE EXPIRY DATE OF THE AFFECTED RED CELLS WAS EXCEEDED. THE CUSTOMER COULD SEND US NEITHER THE COMPLAINT BIOTESTCELL 3 NOR THE MISSED ANTIBODIES. THEREFORE, THE RETENTION SAMPLE OF THE COMPLAINED LOT, WHICH WAS ALREADY EXPIRED, WAS TESTED IN THE QUALITY CONTROL LABORATORIUM. THE TESTING WAS PERFORMED IN THE DIAMED GELSYSTEM WITH AN ANTI-D STANDARD OF IMMUCOR AND AN ANTI-E OF AN INTERLABORATORY COMPARISON. BECAUSE WE HAD NO ADEQUATE ANTI-LE(A) THE ANTI-D STANDARD AND THE ANTI-E WERE USED AS REPRESENTATIVES FOR THE CORRECT REACTION OF THE REAGENT RED BLOOD CELLS. THE ANTI-D STANDARD OF IMMUCOR WAS USED IN TWO DIFFERENT CONCENTRATIONS: 0.05 IU/ML AND 0.025 IU/ML. ALL THREE TESTS (THE TWO ANTI-D DILUTIONS AND THE ANTI-E) REACTED CORRECT POSITIVE WITH THE RETENTION SAMPLE OF BIOTESTCELL 3. IN PARALLEL THE CURRENT LOT OF BIOTESTCELL 3 WHICH HAD REACTED CORRECTLY AT CUSTOMER'S LABORATORIUM WAS ALSO TESTED WITH THE ANTI-D STANDARD OF IMMUCOR AND AN ANTI-E OF AN INTERLABORATORY COMPARISON: ALL REACTIONS WERE CORRECT. IMMUCOR RECOMMENDS IN THEIR INSTRUCTION FOR USE THAT THE ANTI-D STANDARD WITH 0.025 IU/ML SHOULD REACT POSITIVE IN THE SOLID PHASE TECHNIQUES OR TECHNIQUES COMPARABLE. AND THE COMPLAINED LOT OF BIOTESTCELL 3 REACTED CORRECT POSITIVE. MOREOVER IN STABILITY STUDIES THE ANTIGENICITY OF THE REAGENT RED BLOOD CELLS WAS PROVED UNTIL EXPIRY DATE. THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTESTCELL 3 BIOTESTCELL KSZ BIOTEST MEDICAL DIAGNOSTICS GMBH 7924011

    Patients

    Seq Age Sex Outcome Treatment
    1