BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG

    MDR report key: 10454950 · Received August 26, 2020

    Report

    Report Number
    3008344661-2020-00065
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 6, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED TO CORRECT SECTION D2B: PROCODE FROM KSJ TO LOM.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR POTENTIAL FALSE REACTIVE HBSAG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. A REVIEW OF THE RESULTS STATED IN THE TICKET TEXT WAS ALSO PERFORMED. IN-HOUSE TESTING OF REAGENT LOT 15029FN00 WAS COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A TICKET SEARCH FOR LOT 15029FN00 WAS PERFORMED AND INDICATED THAT THE ALINITY I HBSAG ASSAY WAS PERFORMING AS EXPECTED; NORMAL COMPLAINT ACTIVITY WAS OBSERVED. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HBSAG REAGENT DID NOT IDENTIFY ANY TRENDS. IN HOUSE TESTING OF CONTROLS WHICH MIMIC PATIENT SAMPLES WAS COMPLETED USING RETAINED SAMPLES OF LOT 15029FN00; ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. MANUFACTURING DOCUMENTATION WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HBSAG ASSAY, LOT NUMBER 15029FN00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 8P08 THAT HAS A SILIAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53 ARCHITECT (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE REACTIVE ALINITY (B)(6) RESULTS WERE GENERATED FOR A PATIENT. THE CUSTOMER STATED THAT ON (B)(6) 2020 SID (B)(6) GENERATED A RESULT OF 0.16 (REACTIVE). [>/= TO 0.05 IU/ML = REACTIVE]. THIS SAMPLE WAS NOT RECENTRIFUGED AND RETESTED AFTER THIS INITIAL REACTIVE RESULT. THE PATIENT WAS CLINICALLY DIAGNOSED WITH UREMIA AND WAS ASSIGNED TO A DIALYSIS MACHINE DESIGNATED FOR REACTIVE (B)(6) PATIENTS BASED ON THE REACTIVE RESULT. A WEEK LATER, THE CUSTOMER STATED THE SAME PATIENT WAS TESTED AGAIN GENERATED A RESULT OF 0 (NONREACTIVE). THE NEXT DAY THE PATIENT WAS RETESTED AGAIN WITH BOTH THE (B)(6) DILUENT REAGENT AND (B)(6) REAGENT AND GENERATED THE FOLLOWING RESULTS FOR SAMPLE BARCODE NUMBER (B)(6): (B)(6) DILUENT: INITIAL RESULT 0.12 (REACTIVE); RETEST 0 (NONREACTIVE) ; SECOND RETEST 0 (NONREACTIVE). (B)(6): INITIAL 0 (NONREACTIVE), RETEST 0 (NONREACTIVE); SECOND RETEST 0 (NONREACTIVE). CONFIRMATORY TESTING WAS NOT PERFORMED. THERE WAS NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919474 ALINITY I HBSAG HBSAG LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 15029FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ALINITY I PROCESSING MODULE,| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| LIST 03R65-01, SN (B)(6)