BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IH-LISS RACK

    MDR report key: 8774975 · Received July 10, 2019

    Report

    Report Number
    9610824-2019-00030
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSG
    UDI-DI
    07611969952175
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IH-LISS RACKS HAVE NOTICEABLE LOW VOLUMES IN WELLS 9 AND 10 CAUSING A "LIQ ERROR" MESSAGE ON THE IH-1000. THE CUSTOMER PROVIDED IMAGES WHICH CONFIRMED THE REPORTED ISSUE. FURTHERMORE OUR QUALITY CONTROL LABORATORY INVESTIGATED THEIR RETENTION SAMPLES AND COULD CONFIRM THE CUSTOMER´S COMPLAINT. RISK ASSESSMENT: THE SUSPENSION OF RED BLOOD CELLS PREPARED WITH LIS FROM UNDERFILLED WELLS AND THE FOLLOWING DISPENSION INTO IH-CARDS MAY RESULT IN A LIQ-ERROR MESSAGE ON THE IH-1000 OR MAY RESULT IN ABNORMAL PELLET SIZES WHICH MAY CAUSE UNINTERPRETABLE, OR IN VERY RARE CASES, POTENTIALLY ERRONEOUS RESULTS ON THE IH-1000. UNINTERPRETABLE RESULTS MAY REQUIRE RETESTING OR FURTHER RESULT VERIFICATION INCLUDING VISUAL INSPECTION BY THE OPERATOR. IMPACT FOR THE PATIENT: VERY WEAK INCOMPATIBLE CROSSMATCHES MIGHT BE MISSED IN RARE CASES. BASED ON THE RISK ASSESSMENT BMD SENT AN "URGENT MEDICAL DEVICE CORRECTION" LETTER TO AFFECTED CUSTOMERS. IN THIS LETTER THE CUSTOMERS ARE ADVISED TO STOP USING THE AFFECTED LOT OF IH-LISS RACK. FDA WILL BE NOTIFIED OF THIS FIELD ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572648 IH-LISS RACK IH-LISS RACK; 10 RACKS KSG BIO-RAD MEDICAL DIAGNOSTICS GMBH 760000004 07611969952175

    Patients

    Seq Age Sex Outcome Treatment
    1