BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY M HBV AMP KIT

    MDR report key: 17414162 · Received July 28, 2023

    Report

    Report Number
    3005248192-2023-00200
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    February 17, 2023
    Report Date
    July 28, 2023
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MKT
    UDI-DI
    00884999047747
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A RETAIN EVALUATION, CUSTOMER DATA REVIEW, QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: RETAIN EVALUATION: ALINITY M HBV AMP KIT (LIST (B)(4)) LOT 380963 RETAIN SAMPLE WAS TESTED BY THE COMPLAINT SUPPORT TEAM. LOT 380963 MET ALL VALIDITY AND ACCEPTANCE CRITERIA WITH NO ERROR CODES AND ALL TESTING REPLICATES WERE INTERPRETED CORRECTLY BY THE ASSAY SOFTWARE. CUSTOMER DATA REVIEW: REVIEW OF THE CUSTOMER DATA WAS PERFORMED. THE RUNS WHICH INVOLVED THE DISCREPANT RESULTS WERE VALID AND MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE CONTROLS. THE DISCREPANT RESULT PRODUCED A VALID RESULT, AND THE AMPLIFICATION CURVE DID NOT APPEAR ABNORMAL. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M HBV AMP KIT (LIST (B)(4)) LOT 380963 (INCLUDING THE COMPONENTS) DID NOT IDENTIFY ANY ISSUES WHICH RELATED TO THE REPORTED COMPLAINT. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. THE QC AMP KIT MASTER LOT TESTING MET ALL ACCEPTANCE AND VALIDITY SPECIFICATION CRITERIA. CAPA / NON-CONFORMANCE REVIEW: A CAPA REVIEW WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT FOR ALINITY M HBV AMP KIT (LIST (B)(4)) LOT 380963 AND ITS COMPONENTS. THIS CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL ISSUES OR NON-CONFORMITIES RELATED TO THE REPORTED COMPLAINT FOR ALINITY M HBV AMP KIT (LIST (B)(4)) LOT 380963 OR ITS COMPONENTS. ADDITIONALLY, THE REVIEW EVALUATED RECORDS RELATED TO THE LIST NUMBER (B)(4) FOR SIMILAR ISSUES; NO ADDITIONAL RECORDS WERE IDENTIFIED TO BE RELATED TO THE CURRENT INVESTIGATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY COMPLAINTS RELATED TO THE REPORTED ISSUE FOR THE ALINITY M HBV AMP KIT (LIST (B)(4)) LOT 380963. A PRODUCT DEFICIENCY WAS NOT DETERMINED BY THIS EVALUATION FOR THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY COULD NOT BE IDENTIFIED BY THIS REVIEW.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON THE ALINITY M HBV ASSAY. THE CUSTOMER OBTAINED A FALSE POSITIVE RESULT FROM A BONE MARROW DONOR PATIENT. THE TESTED SAMPLE WAS A EDTA PLASMA SAMPLE. THE PATIENT WAS A BONE MARROW DONOR. SID (SAMPLE ID) (B)(6), WAS PROCESSED ON (B)(6) 2023 AND GAVE A TARGET CALL OF 32.66 CT WITH ALL CONTROLS VALID AND A FINAL RESULT OF 19 IU/ML. A FROZEN SAMPLE THAT HAD BEEN TAKEN FROM THE PATIENT WAS THEN RUN AND A RESULT OF NOT DETECTED. THE CUSTOMER ALSO REPORTED THAT RESULTS FROM ALTERNATIVE METHODS AND SEROLOGICAL TESTS WERE NEGATIVE. THE RESULTS WERE REPORTED TO THE PATIENT. ON (B)(6) 2023 THE CUSTOMER REPORTED THAT THE BONE MARROW IS UNDER QUARANTINE AND THE CUSTOMER IS ATTEMPTING TO DETERMINE THE PATIENT IMPACT AS A RESULT OF THE DISCREPANT RESULT. THE PATIENT IS ON PROPOSAL FOLLOW UP PROGRAM. INFORMATION REGARDING THE SAMPLE TYPE WAS COMMUNICATED (B)(6) 2023. PER THE ALINITY M HBV AMP KIT PACKAGE INSERT (53-608059, REVISION 5), THIS EVENT HAS BEEN USED OUTSIDE OF THE INTENDED USE OF THE ASSAY: INTENDED USE THE ALINITY M HBV ASSAY IS AN IN VITRO POLYMERASE CHAIN REACTION (PCR) ASSAY FOR USE WITH THE AUTOMATED ALINITY M SYSTEM TO QUANTITATE HEPATITIS B VIRUS (HBV) DNA IN HUMAN PLASMA OR SERUM. THE ALINITY M HBV ASSAY IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING AND MONITORING RESPONSE TO TREATMENT. THE RESULTS FROM THE ALINITY M HBV ASSAY MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. THIS ASSAY IS NOT INTENDED TO BE USED IN SCREENING BLOOD, BLOOD PRODUCTS, TISSUE OR ORGAN DONORS FOR HBV, OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV INFECTION. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING IF THE BONE MARROW WAS DISCARDED, DIAGNOSIS OR ADDITIONAL PATIENT INFORMATION, THE CURRENT STATUS OF THE BONE MARROW RECIPIENT. THE CUSTOMER WAS NOTIFIED OF THE OFF-LABEL USE OF THE ASSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968458 ALINITY M HBV AMP KIT HEPATITIS VIRAL B DNA DETECTION MKT ABBOTT MOLECULAR, INC. 380963 00884999047747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other