BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS IH-PANEL 11

    MDR report key: 7863238 · Received September 11, 2018

    Report

    Report Number
    9610824-2018-00059
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    July 5, 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. CUSTOMER STATED THAT THE SCREENING AND IDENTIFICATION WITH ORTHO REAGENT RED BLOOD CELLS YIELDED POSITIVE RESULTS (+/- TO 1+) WITH HOMOZYGOUS CELLS (FY+B-) ONLY AND IH-PANEL 11 YIELDED NEGATIVE RESULTS. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT, THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. THEREFORE A TESTING OF OUR QUALITY CONTROL LABORATORY'S RETENTION SAMPLE WAS NOT POSSIBLE. THE CUSTOMER DID NOT RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE NO INVESTIGATION COULD BE CONDUCTED. 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 AUGUST 14TH THE CUSTOMER REPORTED ABOUT A DISCORDANT TEST RESULT OF A SAMPLE DURING THE VALIDATION OF IH 1000, INVOLVING AN ANTI-FYA SPECIMEN . 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 # 8823011) 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
    706757 REAGENT RED BLOOD CELLS IH-PANEL 11 IH-PANEL 11; 11X4 ML KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8823011 07611969952298

    Patients

    Seq Age Sex Outcome Treatment
    1 BIO-RAD GEL PANEL,LOT 8823011,EXP.07/30/18| BIO-RAD GEL PANEL,LOT 8823011,EXP.07/30/18| BIO-RAD IGG-CARD,LOT 760000000040| BIO-RAD IGG-CARD,LOT 760000000040| IH-PANEL 11, LOT 8823011| IH-PANEL 11, LOT 8823011| ORTHO GEL PANEL, LOT VRC246, EXP. 07/17/18| ORTHO GEL PANEL, LOT VRC246, EXP. 07/17/18| ORTHO GEL SCREEN,LOT VSS012,EXP 07/17718| ORTHO GEL SCREEN,LOT VSS012,EXP 07/17718| ORTHO IGG CARD,LOT 032918001-01,EXP.01/11/19| ORTHO IGG CARD,LOT 032918001-01,EXP.01/11/19