BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-K (KEL1)

    MDR report key: 13016376 · Received December 16, 2021

    Report

    Report Number
    9610824-2021-00082
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 23, 2021
    Report Date
    January 12, 2022
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH SERACLONE ANTI-K. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL (QC) LABORATORY TESTED THE COMPLAINT SAMPLE WITH DIFFERENT DONOR SAMPLES AND CONFIRMED THE CUSTOMER´S FINDING. THE CUSTOMER'S COMPLAINT SAMPLE WAS TESTED IN PARALLEL WITH THE RETENTION SAMPLE OF OUR QC AND A REFERENCE LOT. BOTH, THE RETENTION SAMPLE OF THE AFFECTED LOT AS WELL AS THE REFERENCE LOT, SHOWED CORRECT RESULTS. THE COMPLAINT SAMPLE WAS ALSO VISUALLY EXAMINATED: THE COMPLAINT SAMPLE SHOWED NEITHER TURBIDITY NOR IMPURITIES AND LOOKED LIKE THE QC RETENTION SAMPLE. ADDITIONALLY, THE COMPLAINT SAMPLE WAS TESTED FOR POTENCY IN PARALLEL WITH OUR QC'S RETAINED SAMPLE AND THE REFERENCE LOT. THE COMPLAINT SAMPLE SHOWED TWO TITER STEPS LESS THAN THE QC RETAINTED SAMPLE AND THE REFERENCE SAMPLE. THEORETICALLY, A CONTAMINATION WITH ANTI-K, ANTI-KPB, ANTI-JSB OR ANTI-LU(B) COULD HAVE CAUSED THE POSITIVE REACTIONS IN THE COMPLAINT SAMPLE. THEREFORE, OUR QC LAB TESTED THE COMPLAINT SAMPLE WITH A FROZEN SAMPLE OF A KELL ZERO DONOR THAT WAS K, KP(B) AND JS(B) NEGATIVE. THE COMPLAINT SAMPLE SHOWED COMPLETELY NEGATIVE REACTIONS WITH THIS DONOR SAMPLE. THE CORRECT FUNCTION OF THE DONOR SAMPLE WAS CONFIRMED WITH AN ANTI-LU(B). HERE, THE KELL ZERO SAMPLE 3+ REACTED POSITIVELY. THE QC SAMPLE AND THE REFERENCE SAMPLE ALSO SHOWED CORRECTLY NEGATIVE RESULTS WITH THE SAMPLE OF THE KELL ZERO DONOR. BASED ON THIS INVESTIGATION A CONTAMINATION WITH ANTI-LU(B) COULD BE RULED OUT. THERE WERE NOT THE APPROPRIATE RED BLOOD CELLS AVAILABLE TO RULE OUT A CONTAMINATION WITH ANTI-K, ANTI-KP(B) AND ANTI-JS(B). BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - UPP: UNEXPECTED PRODUCT PERFORMANCE. THE TYPE OF CONTAMINATION REMAINED UNKNOWN. WE DID NOT RECEIVE ANY FURTHER COMPLAINT ABOUT THIS LOT AND TOPIC. A GENERAL LOT PROBLEM CAN BE EXCLUDED, ESPECIALLY SINCE OUR QC LAB TESTED BOTH THE FIRST VIAL FILLED AND A VIAL FILLED AFTER THE CUSTOMER'S SAMPLE. THESE TWO VIALS REACTED SPECIFICALLY. ONLY THE CUSTOMER SAMPLE YIELDED A FALSE POSITIVE REACTION. NO OTHER REAGENT WAS FILLED ON THE DAY IN QUESTION THAT COULD HAVE CAUSED A CONTAMINATION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH SERACLONE ANTI-K. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. 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
    1918553 BLOOD GROUPING REAGENT ANTI-K (KEL1) SERACLONE ANTI-K QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 9111010-01 07611969951574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown