BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM CHAGAS

    MDR report key: 6103038 · Received November 15, 2016

    Report

    Report Number
    1415939-2016-00112
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    July 10, 2016
    Report Date
    December 21, 2016
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MIU
    UDI-DI
    00380740062941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN-PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A DEVICE HISTORY REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE FROM THE CUSTOMER. A SPECIFICITY TESTING PROTOCOL WAS EXECUTED USING LOT 60017M500 AND MET ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. THE DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS RELATED TO THE CUSTOMER'S OBSERVATIONS. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE PRISM CHAGAS REAGENT, LIST NUMBER (B)(4), LOT NUMBER 60017M500, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED AN INCREASE IN REACTIVE RESULTS HAS BEEN GENERATED WHILE USING THE PRISM CHAGAS ASSAY ON THE PRISM 6 CHANNEL ANALYZER. DURING THE TIMEFRAME OF (B)(6) 2016 TO (B)(6) 2016, TWELVE SPECIMENS WHICH HAD BEEN REPEAT REACTIVE WERE NEGATIVE WHEN TESTED USING THE ORTHO METHOD. SPECIFICALLY THE CUSTOMER INDICATED THAT FALSE POSITIVE RESULTS WERE GENERATED ON (B)(6) 2016 AND (B)(6) 2016 USING LOT 60017M500. NO SPECIFIC PATIENT DATA HAS BEEN PROVIDED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753964 PRISM CHAGAS CHAGAS MIU ABBOTT LABORATORIES 60017M500 00380740062941

    Patients

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