BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS IH-PANEL 11

    MDR report key: 7863235 · Received September 11, 2018

    Report

    Report Number
    9610824-2018-00058
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    June 13, 2018
    Report Date
    October 23, 2018
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DISCORDANT RESULT DURING VALIDATION INVOLVING AN ANTI-FYA ON IH-1000. THE CUSTOMER STATED THAT IDENTIFICATION WITH ORTHO REAGENT RED BLOOD CELLS YIELDED POSITIVE RESULTS (1+) WITH HOMOZYGOUS CELLS (FY+B-) AND +/- WITH HETEROZYGOUS CELLS (FYA+B+). THE PATIENT SAMPLE YIELDED FALSE NEGATIVE RESULTS WITH IH-PANEL 11. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE A TESTING OF OUR QUALITY LABORATORY'S RETENTION SAMPLE WAS NOT POSSIBLE. THE CUSTOMER DID ALSO NOT SEND IN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE NO INVESTIGATION COULD BE CARRIED OUT. 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

    ON (B)(6) THE CUSTOMER REPORTED ABOUT A DISCORDANT TEST RESULT OF A SAMPLE DURING THE VALIDATION OF IH 1000, INVOLVING AN ANTI-FYA . THE SCREEN OF THE PATIENT SAMPLE TESTED WITH ORTHO CELLS SHOWED POSITIVE RESULTS WITH HOMOZYGOUS CELLS (1+) AND HETEROZYGOTE CELLS (+/-) WHEREAS THE TESTING WITH BIO-RAD IH-PANEL CELLS YIELDED INTO NEGATIVE TEST RESULTS. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT (IH-PANEL 11/ LOT # 8819011) AND THE PATIENT SAMPLE WHICH HAD CAUSED THE DISCORDANT TEST RESULT. AT THE TIME THE COMPLAINT WAS REPORTED, THE EXPIRATION DATE OF THE PRODUCT WAS ALREADY EXCEEDED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. INVESTIGATION OF OUR QUALITY CONTROL LABORATORY IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706751 REAGENT RED BLOOD CELLS IH-PANEL 11 IH-PANEL 11; 11X4 ML KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8819011 07611969952298

    Patients

    Seq Age Sex Outcome Treatment
    1 BIO-RAD GEL CARD, LOT 8717100, EXP. 08/28/2018| BIO-RAD GEL CARD, LOT 8717100, EXP. 08/28/2018| BIO-RAD GEL CARD, LOT 8819011, EXP.. 07/02/2018| BIO-RAD GEL CARD, LOT 8819011, EXP.. 07/02/2018| ORTHO GEL PANEL, LOT VRC245, EXP. 06/19/2018| ORTHO GEL PANEL, LOT VRC245, EXP. 06/19/2018| ORTHO IGG CARD, LOT 020718001-63| ORTHO IGG CARD, LOT 020718001-63