BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HCV

    MDR report key: 4131442 · Received October 1, 2014

    Report

    Report Number
    1415939-2014-00213
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). (B)(6). THE CUSTOMER INDICATED THAT 2 (B)(6) LOT NUMBERS WERE IN USE ON 3 (B)(6) ANALYZERS. THE CUSTOMER DID NOT HAVE AVAILABLE THE PATIENT RESULTS GENERATED USING THE (B)(6) ASSAYS OR WHICH PATIENTS WERE TESTED USING WHICH LOT NUMBER OR ANALYZER, ONLY THAT THE RESULTS WERE (B)(6) AND PROVIDED 2 LOT NUMBERS IN USE: 38849LI00 AND 39720LI00. AN EVALUATION IS IN-PROCESS.

    Additional Manufacturer Narrative · 1

    LOT NUMBER 38849LI00, MANUFACTURE DATE: 05/2014, EXPIRATION DATE: 11/24/2014, LOT NUMBER 39720LI00, MANUFACTURE DATE: 05/2014, EXPIRATION DATE: 12/28/2014. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. A SPECIFICITY TESTING PROTOCOL WAS EXECUTED USING LOTS 38849LI00 AND 39720LI00; EACH LOT MET ACCEPTANCE CRITERIA WHICH DETERMINED THE REAGENTS ARE PERFORMING ACCEPTABLY. 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, LOTS 38849LI00 AND 39720LI00, WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE (B)(6). THE CUSTOMER INDICATED THAT 6 DONORS WERE (B)(6). NO SPECIFIC (B)(6) RESULTS WERE PROVIDED FROM THE CUSTOMER. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611782 PRISM HCV ANTI-HCV MZO ABBOTT LABORATORIES MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM 6 CHANNEL ANALYZER LN 06A36-04 , SN (B)(4)| PRISM 6 CHANNEL ANALYZER LN 06A36-07, SN (B)(4)| PRISM 6 CHANNEL ANALYZER LN 06A36-04 , SN (B)(4)| PRISM 6 CHANNEL ANALYZER LN 06A36-04 , SN (B)(4)| PRISM 6 CHANNEL ANALYZER LN 06A36-07, SN (B)(4)| PRISM 6 CHANNEL ANALYZER LN 06A36-04 , SN (B)(4)