BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-COM

    MDR report key: 9115079 · Received September 25, 2019

    Report

    Report Number
    9610824-2019-00053
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    August 27, 2019
    Report Date
    February 21, 2023
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969234417
    PMA / PMN Number
    BK180275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ATYPICAL RESULTS OF ONE PATIENT. THE CUSTOMER PROVIDED TWO DAILY JOURNAL IMAGES OF TYPE AND SCREEN USING IH-1000 ON THE SAME PATIENT. TWO SAMPLES WERE COLLECTED APPROXIMATELY A WEEK APART WITH SIMILAR RESULTS. THE BACK TYPE AND THE ANTIBODY SCREEN REACTIONS WERE CLEARLY ATYPICAL. THE SOFTWARE IH-COM, VERSION 5.0 INTERPRETED THESE RESULTS AS NEGATIVE, AND THERE ARE VERY CLEARLY NOT NEGATIVE, BUT ALTHOUGH CLEARLY NOT TYPICAL POSITIVE EITHER. IN BOTH CASES THE ABO/RH WAS NTD (NOT TO DETERMINE) DUE TO FORWARD REVERSE MISMATCH. THE RESULTS WERE CORRECTED BY THE USER BUT THE RESULTS WERE FLAGGED NOT FOR THE REASON THEY SHOULD HAVE BEEN. THE PATIENT HAS A HISTORY OF MULTIPLE MYELOMA AND THE EXAMPLES WERE EXPECTED TO PRESENT WITH ATYPICAL RESULTS. OUR INVESTIGATION CONFIRMED THAT ALL TESTS WERE CORRECTLY PERFORMED BY THE INSTRUMENT AND NO ISSUE OR MALFUNCTION ON THE INSTRUMENT WAS IDENTIFIED (FROM THE TRACE FILES ANALYSES) AND THE WELLS A1 AND B WERE INTERPRETED AS NEGATIVE. ACCORDING TO THE ANALYSIS OUR TECHNICIAN CONDUCTED THE DETECTION OF THE DOUBLE POPULATION ON THE REVERSE GROUP AND THE AB SCREENING TEST WAS DEACTIVATED.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ATYPICAL RESULTS OF ONE PATIENT. THE CUSTOMER PROVIDED TWO DAILY JOURNAL IMAGES OF TYPE AND SCREEN USING IH-1000 ON THE SAME PATIENT. TWO SAMPLES WERE COLLECTED APPROXIMATELY A WEEK APART WITH SIMILAR RESULTS. THE BACK TYPE AND THE ANTIBODY SCREEN REACTIONS WERE CLEARLY ATYPICAL. THE SOFTWARE IH-COM, VERSION 5.0 INTERPRETED THESE RESULTS AS NEGATIVE, AND THERE ARE VERY CLEARLY NOT NEGATIVE, BUT ALTHOUGH CLEARLY NOT TYPICAL POSITIVE EITHER. IN BOTH CASES THE ABO/RH WAS NTD (NOT TO DETERMINE) DUE TO FORWARD REVERSE MISMATCH. THE RESULTS WERE CORRECTED BY THE USER BUT THE RESULTS WERE FLAGGED NOT FOR THE REASON THEY SHOULD HAVE BEEN. THE PATIENT HAS A HISTORY OF MULTIPLE MYELOMA AND THE EXAMPLES WERE EXPECTED TO PRESENT WITH ATYPICAL RESULTS. THE INVESTIGATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915526 IH-COM IH-COM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 5.0.10 07611969234417

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown IH-1000, # 5100073| IH-1000, # 5100073| IH-CARD ABO/D(DVI-)+REV A1,B, # 8903080| IH-CARD ABO/D(DVI-)+REV A1,B, # 8903080| IH-CARD AHG ANTI-IGG, # 88500070| IH-CARD AHG ANTI-IGG, # 88500070| IH-CELL A1&B, # 8927011| IH-CELL A1&B, # 8927011| IH-CELL I-II-III, # 8927011| IH-CELL I-II-III, # 8927011