BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HCV

    MDR report key: 4898749 · Received July 8, 2015

    Report

    Report Number
    1415939-2015-00023
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    March 15, 2015
    Report Date
    March 25, 2015
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2015-00035. ON JULY 7, 2015 IT WAS IDENTIFIED THAT: THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED. THIS REPORT WAS GENERATED TO DOCUMENT (B)(6) AS THE MANUFACTURE LOCATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06A52, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06D18. (B)(6). (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE FROM THE CUSTOMER. A SENSITIVITY TESTING PROTOCOL WAS EXECUTED USING LOT 45613LI00. THE TESTING MET THE ACCEPTANCE REQUIREMENTS WHICH INDICATED THAT THE LOT IS PERFORMING AS EXPECTED. NO ISSUES WERE IDENTIFIED WHICH WOULD INDICATE A PRODUCT DEFICIENCY FROM THE BATCH RECORD REVIEW. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION A DEFICIENCY OF THE PRISM (B)(6) REAGENT LIST NUMBER 06A52, LOT 45613LI00, WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSE NEGATIVE PRISM (B)(6) RESULT OF 0.40 S/CO WAS GENERATED. THE PATIENT HAS A HISTORY OF A POSITIVE (B)(6) RESULT IN 2010 ON THE AXSYM ANALYZER. THE PATIENT WAS ALSO TESTED USING OTHER ANALYZERS (ARCHITECT) GENERATING NEGATIVE RESULTS OF 0.66 ((B)(6) 2015), RETESTED: 0.62 ((B)(6) 2015), 0.61((B)(6) 2015), AND 0.57 ((B)(6) 2015). THE SAMPLE WAS ALSO PROCESSED ON TWO ADDITIONAL ARCHITECT ANALYZERS AT ANOTHER LABORATORY AND RESULTS OF 0.30 AND 0.35 S/CO WERE GENERATED ON ONE ANALYZER AND 0.64 S/CO ON THE OTHER ANALYZER. AN IMMUNOBLOT WAS RUN (INNOLIA HCV SCORE) AND WAS POSITIVE. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444379 PRISM HCV ANTI-HCV MZO ABBOTT LABORATORIES 45613LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM 6 CHANNEL ANALYZER| LN 06A36-04, SN (B)(4)