BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PRISM HCV ASSAY KIT

    MDR report key: 11656353 · Received April 13, 2021

    Report

    Report Number
    1415939-2021-00014
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    February 26, 2021
    Report Date
    June 9, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    QHM
    UDI-DI
    00380740062996
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. (B)(6). ALL AVAILABLE PATIENT INFORMATION INCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE THIS MDR IS BEING SUBMITTED FOR THE PRISM (B)(6) REAGENT, LIST 06D18-68

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS ABBOTT PRISM CHAGAS, LIST NUMBER (LN) (B)(4), LOT 15094M700, ABBOTT PRISM HCV, (B)(4), LOT 20049M700 , AND ABBOTT PRISM HTLV-I/HTLV-II, (B)(4), LOT 22075M700 IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR ALL LOTS INVOLVED. A REVIEW OF TICKET TRENDING WAS PERFORMED AN NO TREND WAS IDENTIFIED FOR THE CUSTOMER COMPLAINT FOR THE ABBOTT PRISM CHAGAS, LIST NUMBER (LN) (B)(4)), ABBOTT PRISM HCV, (B)(4), AND THE ABBOTT PRISM HTLV-I/HTLV-II, (B)(4) REAGENTS. A REVIEW OF CUSTOMER DATA WAS PERFORMED INCLUDING THE REPEAT REACTIVE RATES (RRR) FOR ABBOTT PRISM CHAGAS LOT 15094M700, ABBOTT PRISM HCV LOT 20049M700 AND ABBOTT PRISM HTLV-I/HTLV-II LOT 22075M700. IT WAS FOUND THAT THE CUSTOMER RRR WERE WITHIN THE PACKAGE INSERT RANGES FOR DATA FOR ABBOTT PRISM CHAGAS LOT 15094M700 AND ABBOTT PRISM HCV LOT 20049M700. FOR ABBOTT PRISM HTLV-I/HTLV-II LOT 22075M700, THE (B)(4) RRR EXCEEDED THE OVERALL TOTAL DONOR UPPER 95% CONFIDENCE LIMIT BUT WAS STILL WITHIN THE RANGE OF EXPECTED PERFORMANCE FOR ANY SINGLE ABBOTT PRISM HTLV-I/HTLV-II LOT ((B)(4)) AS SHOWN IN THE PACKAGE INSERT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. ADDITIONALLY, LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER ISSUE. BASED ON THE RESULTS OF THIS INVESTIGATION, THERE IS NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE PRISM CHAGAS LOT 15094M700, PRISM HCV LOT 20049M700 AND PRISM HTLV-I/HTLV-II LOT 22075M700. THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED (B)(6) PRISM CHAGAS, PRISM (B)(6), AND PRISM HTLV RESULTS WERE GENERATED. THE CUSTOMER STATED THAT THE SAMPLES WERE ARCHIVED THEN RUN ON THE ALINITY S FOR VALIDATION TESTING AS ¿KNOWN¿ (B)(6) BUT THEY GENERATED (B)(6) RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6)- (B)(6) 2021 PRISM CHAGAS REPEAT PRISM CHAGAS REPEAT REACTIVE (1.40, 1.47, 1.39 S/CO) (LOT 15094M700); (B)(6) 2021- ALINITY S NON-REACTIVE (0.14 S/CO); ESA INDETERMINATE SID (B)(6)- (B)(6) 2021 PRISM CHAGAS REPEAT REACTIVE (1.78, 2.61, 2.55 S/CO) (LOT 15094M700); (B)(6) 2021- ALINITY S NON-REACTIVE (0.02 S/CO); ESA NEGATIVE SID (B)(6) - (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.94, 1.88, 1.76 S/CO);(B)(6) 2021- ALINITY S NON-REACTIVE (0.14 S/CO); MP HTLV BLOT NEGATIVE SID (B)(6)- (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.93, 2.01, AND 1.99 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.13 S/CO); MP HTLV BLOT INDETERMINATE SID (B)(6)- (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.25, 1.47, 1.39 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.16 S/CO); MP HTLV BLOT INVALID SID (B)(6)- (B)(6) 2021 PRISM (B)(6) REPEAT (B)(6); (B)(6) 2021- ALINITY S (B)(6); ORTHO (B)(6), ROCHE NAT (B)(6) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REPEAT REACTIVE PRISM CHAGAS, PRISM HCV, AND PRISM HTLV RESULTS WERE GENERATED. THE CUSTOMER STATED THAT THE SAMPLES WERE ARCHIVED THEN RUN ON THE ALINITY S FOR VALIDATION TESTING AS ¿KNOWN¿ POSITIVES BUT THEY GENERATED NON-REACTIVE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(4)- (B)(6) 2021 PRISM CHAGAS REPEAT REACTIVE (1.40, 1.47, 1.39 S/CO) (LOT 15094M700); (B)(6) 2021- ALINITY S NON-REACTIVE (0.54 S/CO); ESA INDETERMINATE. SID (B)(4)- (B)(6) 2021 PRISM CHAGAS REPEAT REACTIVE (1.78, 2.61, 2.55 S/CO) (LOT 15094M700); (B)(6) 2021- ALINITY S NON-REACTIVE (0.02 S/CO); ESA NEGATIVE. SID (B)(4)- (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.94, 1.88, 1.76 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.14 S/CO); MP HTLV BLOT NEGATIVE. SID (B)(4)- (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.93, 2.01, AND 1.99 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.13 S/CO); MP HTLV BLOT INDETERMINATE. SID (B)(4)- (B)(6) 2021 PRISM HTLV REPEAT REACTIVE (1.25, 1.47, 1.39 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.16 S/CO); MP HTLV BLOT INVALID. SID (B)(4)- (B)(6) 2021 PRISM HCV REPEAT REACTIVE (1.26, 1.20, 1.24 S/CO); (B)(6) 2021- ALINITY S NON-REACTIVE (0.06 S/CO); ORTHO HCV NONREACTIVE, ROCHE NAT NEGATIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557189 ABBOTT PRISM HCV ASSAY KIT HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43, NS5) QHM ABBOTT LABORATORIES 20049M700 00380740062996

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM 6 CHANNEL-CE, 06A36-04, 1174| PRISM 6 CHANNEL-CE, 06A36-04, 1174| PRISM CHAGAS US A, 07K35-68, 15094M700| PRISM CHAGAS US A, 07K35-68, 15094M700| PRSM HTLV RGT KIT, 06E50-68, 22075M700| PRSM HTLV RGT KIT, 06E50-68, 22075M700