BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG

    MDR report key: 10487681 · Received September 3, 2020

    Report

    Report Number
    9610824-2020-00063
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 17, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHS
    UDI-DI
    07611969952168
    PMA / PMN Number
    125529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A FALSE NEGATIVE REACTION OF ONE DONOR SAMPLE WITH IH-CARD AHG ANTI-IGG AND IH-CELL I-II-III. THE CUSTOMER PERFORMED THE TEST MANUALLY. HE STATED THAT THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-FYB. THE ANTIBODY WAS DETECTED IN THE SOLID PHASE METHOD AND THE GEL METHOD OF A COMPETITOR. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG FOR INVESTIGATIONAL TESTING. OUR QC LABORATORY MANUALLY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT IH-CARD AHG ANTI-IGG USING THE IH-CELL I-II-III LOT 8027011, AS USED AT THE CUSTOMER SITE. THE TESTING WAS PERFORMED WITH IH-INCUBATOR L AS WELL AS IH-CENTRIFUGE L. THE FOLLOWING SAMPLES WERE USED FOR THE ANTIBODY SCREENING TEST: 3 DONOR SAMPLES EXPECTED TO BE NEGATIVE. 3 KNOWN ANTI-FYA (POLYCLONAL). 1 KNOWN ANTI-E (POLYCLONAL). 1 KNOWN ANTI-FYB (POLYCLONAL). ALL NEGATIVE SAMPLES USED REACTED CLEARLY NEGATIVE. THE REACTIONS WITH THE KNOWN ANTIBODIES WERE SPECIFIC. BOTH FYB-ANTIGEN POSITIVE TEST CELLS REACTED WITH A REACTION STRENGTH OF 3+. THE CUSTOMER STATES THAT BOTH HOMOZYGOUS FYB-ANTIGEN POSITIVE TEST CELLS REACTED NEGATIVE AND THE COMPARED TEST CELLS FROM ORTHO REACTED ONLY WITH ONE OF TWO FYB-ANTIGEN POSITIVE TEST CELLS. TESTING BY QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF IH-CARD AHG ANTI-IGG LOT 8012210 FUNCTIONS CORRECTLY. FURTHERMORE, THE RETENTION SAMPLE OF THE REAGENT RED BLOOD CELLS IH-CELL I-II-III LOT 8027011, AS USED BY CUSTOMER, ALSO REACTED CLEARLY POSITIVE WITH KNOWN ANTIBODIES. THE RESULTS OF THE CUSTOMER COULD NOT BE CONFIRMED. WE DID NEITHER RECEIVE ANY FURTHER INFORMATION ABOUT THE PERFORMED TEST AT THE CUSTOMER'S SITE NOR ABOUT THE REACTION STRENGTH, WHICH WAS YIELDED USING THE ORTHO TEST. THEREFORE, THE NON-REACTION WITH IH-CELL I-II-III COULD MAYBE BE EXPLAINED DUE TO THE PRESENCE OF AN ANTI-FYB OF LOW CONCENTRATION. WE WOULD LIKE TO POINT OUT THAT NO SINGLE SEROLOGICAL ANTIBODY SCREENING TECHNIQUE CAN PROVIDE THE OPTIMUM REACTIONS CONDITIONS FOR ALL RED CELL SPECIFICITIES. AS NO MATERIAL WAS SUBMITTED, THE CAUSE OF MISSED ANTIBODY DETECTION AT THE CUSTOMER'S SITE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE DONOR SAMPLE WITH IH-CARD AHG ANTI-IGG AND IH-CELL I-II-III. THE CUSTOMER PERFORMED THE TEST MANUALLY. HE STATED THAT THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-FYB. THE ANTIBODY WAS DETECTED IN THE SOLID PHASE METHOD AND THE GEL METHOD OF A COMPETITOR. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG FOR INVESTIGATIONAL TESTING AND OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE TEST RESULT. IN THE MEANTIME OUR QUALITY CONTROL LABORATORY MANUALLY TESTED THEIR RETENTION SAMPLE OF IH-CARD AHG ANTI-IGG AND IH-CELL I-II-III WITH DONOR SAMPLES AND KNOWN ANTIBODIES, E.G. ANTI-FYB, ANTI-FYA AND ANT-E. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. 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
    950960 ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) (GREEN) IH-CARD AHG ANTI-IGG IH-CARD AHG ANTI-IGG (RABBIT); 48 CARD QHS BIO-RAD MEDICAL DIAGNOSTICS GMBH 8012210 07611969952168

    Patients

    Seq Age Sex Outcome Treatment
    1 IH-CELL I-II-III, LOT 8027011| IH-CELL I-II-III, LOT 8027011