BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS IH-CELL A1 & B

    MDR report key: 11812537 · Received May 12, 2021

    Report

    Report Number
    9610824-2021-00032
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    February 10, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952243
    PMA / PMN Number
    125208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE 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 A FALSE POSITIVE REACTION OF A CAP SURVEY SAMPLE WITH IH-CELL A1&B. THE CAP SURVEY SAMPLE HAD BLOOD GROUP AB AND WOULD THEREFORE BE EXPECTED TO REACT NEGATIVELY WITH IH-CELL A1&B. THE CUSTOMER INFORMED US THAT THE CAP SURVEY SAMPLE ADDITIONALLY CONTAINED AN ANTI-S. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE OF IH-CELL A1&B FOR INVESTIGATIONAL TESTING AND A SMALL AMOUNT OF THE CAP SURVEY SAMPLE. OUR QUALITY CONTROL LABORATORY TESTED MANUALLY THE COMPLAINT SAMPLE WITH THE CAP SURVEY SAMPLE. THE REACTIONS WITH IH-CELL A1&B WERE NEGATIVE. ADDITIONALLY, THE CAP SURVEY SAMPLE WAS MANUALLY TESTED WITH OUR QC LAB'S RETENTION SAMPLE. IH-CELL B SHOWED A WEAK POSITIVE REACTION, WHILE THE REACTION WITH IH-CELL A1 WAS NEGATIVE. FURTHERMORE, A KNOWN ANTI-S (MONOCLONAL, IGM) WAS TESTED WITH BOTH IH-CELL A1&B, THE COMPLAINT SAMPLE RETURNED BY THE CUSTOMER AND OUR QC LAB'S RETENTION SAMPLE. IN BOTH CASES IH-CELL A1&B SHOWED CLEARLY POSITIVE RESULTS. IH-CELL A1&B CONSISTS OF A POOL OF TWO DONORS EACH. INDIVIDUAL DONORS ARE TESTED FOR THE PRESENCE OF S ANTIGEN. THREE OF THE FOUR DONORS WERE S POSITIVE. THE CAP SURVEY SAMPLE WAS ALSO TESTED IN THE ANTIBODY SCREENING TEST IN THE TUBE TECHNIQUE. THE TESTING WAS PERFORMED WITH AN INCUBATION AT ROOM TEMPERATURE, AN INCUBATION WITH LISS AND THE INDIRECT ANTIGLOBULIN TEST. THE CAP SURVEY SAMPLE SHOWED A STRONG POSITIVE RESULT IN ALL THREE TESTING APPROACHES ONLY WITH THE S+S- SCREENING CELL. THE TEST RESULTS SHOWED THAT THE ANTI-S CONTAINED AN IGM PORTION. ADDITIONALLY, THE COMPLAINT SAMPLE WAS TESTED MANUALLY WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. BASED ON THE OUTCOME OF THE INVESTIGATION AND THE INFORMATION PROVIDED BY CUSTOMER THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - EPP (EXPECTED PRODUCT PERFORMANCE). A POSITIVE REACTION OF THE CAP SURVEY SAMPLE WITH IH-CELL A1&B WAS PARTIALLY CONFIRMED. THE POSITIVE REACTION WAS NOT CAUSED BY AN ERRONEOUS PRODUCT IH-CELL A1&B BUT BY THE PRESENCE OF AN ANTI-S OF THE IGM TYPE IN THE CAP SURVEY SAMPLE. IH-CELL A1&B CONSISTS OF A POOL OF TWO DONORS EACH. THREE OF THE FOUR DONORS WERE S POSITIVE. TESTING BY THE QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF IH-CELL A1&B FUNCTIONS CORRECTLY. 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
    707035 REAGENT RED BLOOD CELLS IH-CELL A1 & B IH-CELL A1 & B; 2X10 ML QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 9110011 07611969952243

    Patients

    Seq Age Sex Outcome Treatment
    1