BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HCV

    MDR report key: 9475721 · Received December 16, 2019

    Report

    Report Number
    1415939-2019-00231
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    June 24, 2019
    Report Date
    March 9, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    QHM
    UDI-DI
    00380740062996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF THE MANUFACTURING DOCUMENTATION, REVIEW OF FIELD DATA, AND A REVIEW OF LABELING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF COMPLAINT TRENDING REPORTS DID NOT IDENTIFY ANY TRENDS FOR THE ABBOTT PRISM HCV ASSAY. REVIEW OF COMPLAINT ACTIVITY DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR REAGENT LOT 03109M700. FIELD DATA WAS REVIEWED TO EVALUATE INITIAL REACTIVE RATE, REPEAT REACTIVE RATE AND SPECIFICITY OF REAGENT LOT 03109M700. THE INITIAL REACTIVE RATE WAS 0.10% AND REPEAT REACTIVE RATE WAS 0.08%, WHICH ARE WITHIN PACKAGE INSERT SPECIFICATIONS. ADDITIONALLY, ASSUMING A ZERO PREVALENCE OF HCV FOR THE TESTED SAMPLES, THE SPECIFICITY OF LOT 03109M700 WOULD BE WITHIN PACKAGE INSERT SPECIFICATIONS. MANUFACTURING DOCUMENTATION FOR THE REAGENT LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. ADDITIONALLY, A REVIEW OF LABELING CONCLUDED THAT THE ISSUE WAS SUFFICIENTLY ADDRESSED. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ABBOTT PRISM HCV ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN ERROR WAS IDENTIFIED ON FEBRUARY 13, 2020. THE INCORRECT PRODUCT CODE OF MZO (SECTION D.2B) WAS USED IN THE PREVIOUS SUBMISSIONS. THE CORRECT CODE IS QHM, THIS REPORT IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE. NO FURTHER CHANGES OR CORRECTIONS TO THE PRODUCT INFORMATION OR EVALUATION ARE NEEDED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: MULTIPLE = (B)(6). PATIENT INFORMATION: NO FURTHER DONOR INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ABBOTT PRISM HCV RESULTS FOR TWO DONOR SAMPLES. THE CUSTOMER INDICATED THE DONORS' PREVIOUS AND SUBSEQUENT DONATION WERE NON-REACTIVE. DONOR 1: (B)(6) 2019 ID (B)(6) NON-REACTIVE, (B)(6) 2019 ID (B)(6) REPEAT REACTIVE, (B)(6) 2019 ID (B)(6) NON-REACTIVE. DONOR 2: (B)(6) 2019 ID (B)(6)NON-REACTIVE, (B)(6) 2019 ID (B)(6) REPEAT REACTIVE, (B)(6) 2019 ID (B)(6) NON-REACTIVE. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270958 PRISM HCV ANTI-HCV QHM ABBOTT LABORATORIES 03109M700 00380740062996

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(6) AND 1422.| 01399-96 AND 1422| ABBOTT PRISMNEXT 6 CHANNEL ANALYZER,| ABBOTT PRISMNEXT 6 CHANNEL ANALYZER,| ABBOTT PRISMNEXT 6 CHANNEL ANALYZER,| AND 1422| LIST 06A36-11, SERIALS (B)(6) ,| LIST 06A36-11, SERIALS (B)(6) ,| LIST 06A36-11, SERIALS (B)(6) , (B)(6)