BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 10795924 · Received November 5, 2020

    Report

    Report Number
    3002809144-2020-01095
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 19, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I ANTI-HBC II REAGENT KIT, LIST NUMBER 07P87-77, AND MANUFACTURING SITE ABBOTT GMBH, DEU IN SECTION D OF THIS REPORT TO ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, AND MANUFACTURING SITE OF ABBOTT GMBH, DEU. MDR NUMBER 3002809144-2020-01124-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P84. PATIENT IDENTIFIER = (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NONREACTIVE ALINITY I (B)(6) II RESULTS FOR 5 PATIENTS WHILE RUNNING ON THE ALINITY I PROCESSING MODULE. DURING AN ON-SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE PRE-EXCITATION LIQUID BOTTLE WAS EMPTY BUT THE ANALYZER STILL SHOWED IT AT 93% FULL. THE FSE REPLACED THE LIQUID SENSOR. THE CUSTOMER PROVIDED THE FOLLOWING PATIENT DATA ON (B)(6) 2020 (CUTOFF RANGE IS 1.00 S/CO): SID (B)(6) = INITIAL = 0.04 S/CO (NONREACTIVE), REPEAT = 4.71 S/CO (REACTIVE); SID (B)(6) = INITIAL = 0.00 S/CO (NONREACTIVE), REPEAT = 6.83 S/CO (REACTIVE); SID (B)(6) = INITIAL = 0.00 S/CO (NONREACTIVE), REPEAT = 5.42 S/CO (REACTIVE); SID (B)(6) = INITIAL = 0.00 S/CO (NONREACTIVE), REPEAT = 3.44 S/CO (REACTIVE); SID (B)(6) = INITIAL = 0.00 S/CO (NONREACTIVE), REPEAT = 4.22 S/CO (REACTIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257681 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 18443BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY I PROCESSING MODU, 03R65-01, (B)(4)| ALNTY I PROCESSING MODU, 03R65-01, (B)(4)