BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-K (KEL1)

    MDR report key: 10704820 · Received October 20, 2020

    Report

    Report Number
    9610824-2020-00071
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 23, 2020
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969951574
    PMA / PMN Number
    125230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WEAKENED POSITIVE AND FALSE NEGATIVE REACTIONS WITH SERACLONE ANTI-K (REF #808090100, LOT #8005050-01). THE CUSTOMER SUBMITTED HER TWO VIALS SERACLONE ANTI-K AND THE PANEL CELL THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. OUR QUALITY CONTROL LABORATORY TESTED SERACLONE ANTI-K FOR POTENCY AND SPECIFICITY. TEST METHOD FOR POTENCY AND POSITIVE SPECIFICITY: INCUBATION FOR 5 MINUTES AT ROOM TEMPERATURE, CENTRIFUGATION FOR 20 SECONDS AT 823 X G. TEST METHOD FOR NEGATIVE SPECIFICITY: INCUBATION FOR 5 MINUTES AND 60 MINUTES AT ROOM TEMPERATURE AND 60 MINUTES AT 37 °C WITH SUBSEQUENT CENTRIFUGATION. WITHIN THE POTENCY TESTING THE COMPLAINT SAMPLES (BOTH VIALS) WERE TESTED IN PARALLEL WITH OUR QUALITY CONTROL LAB'S RETENTION SAMPLE AND A REFERENCE LOT (LOT #8013040-01). THE MINIMUM TITER OF 16 WAS EXCEEDED BY ALL VIALS. FOR THE SPECIFICITY TESTING WE USED THE IMMUCOR PANEL CELL PROVIDED BY THE CUSTOMER, HETEROZYGOUS CELLS OF BIOTESTCELL (BIOTESTCELL P LOT #2041011-00 AND CELL #2 OF BIOTESTCELL-I11 LOT #8041011-00) AND CELL #7 OF PANOCELL 10 (LOT #35435). ALL REAGENT RED BLOOD CELLS YIELDED CORRECTLY POSITIVE RESULTS. BASED ON OUR TEST RESULTS WE CANNOT CONFIRM THE CUSTOMER´S FINDING. THE VIALS SUBMITTED BY THE CUSTOMER SHOWED COMPARABLE RESULTS TO THE RETENTION SAMPLE AS WELL AS THE REFERENCE LOT. WE DID NEITHER OBSERVE ANY WEAKENED NOR FALSE NEGATIVE RESULTS. ADDITIONALLY THE TEST FOR NEGATIVE SPECIFICITY WAS PERFORMED USING TWO DIFFERENT K NEGATIVE RED BLOOD CELLS. ALL VIALS (BOTH OF CUSTOMER, RETENTION SAMPLE AND REFERENCE LOT) MET THE ACCEPTANCE CRITERION AND SHOWED CORRECTLY NEGATIVE RESULTS. THE ROOT CAUSE OF THE FALSE NEGATIVE RESULTS AT CUSTOMER´S SITE REMAINS UNKNOWN. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WEAK RESPECTIVELY FALSE NEGATIVE REACTIONS WHEN USING SERACLONE ANTI-K LOT 8005050-01. THE CUSTOMER TESTED THE REAGENT AGAINST MULTIPLE K+ REAGENT RED CELLS AND WAS GETTING NEGATIVE OR WEAK POSITVE RESULTS FOR HER POSITVE CONTROL. INVESTIGATION OF THIS COMPLAINT IS STILL ONGOING, SO IS TESTING IN OUR QUALITY CONTROL LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170986 BLOOD GROUPING REAGENT ANTI-K (KEL1) SERACLONE ANTI-K QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8005050-01 07611969951574

    Patients

    Seq Age Sex Outcome Treatment
    1