BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM 6 CHANNEL ANALYZER

    MDR report key: 5191277 · Received October 30, 2015

    Report

    Report Number
    1628664-2015-00271
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 1, 2015
    Report Date
    December 23, 2015
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZA
    PMA / PMN Number
    BK970042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN-PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A DESIGN HISTORY RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF PRODUCT LABELING. RETURN MATERIAL WAS NOT AVAILABLE. A SPECIFICITY TESTING PROTOCOL WAS EXECUTED USING (B)(6), LIST NUMBER 7G46-48, LOT NUMBER 52851LI00 AND PRISM REACTION TRAYS,LIST NUMBER 5A07-01, LOT NUMBER 52082M500. TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE THE PRODUCT IS MEETING EXPECTED SPECIFICITY REQUIREMENTS AND ARE PERFORMING ACCEPTABLY. A DESIGN HISTORY REVIEW DID NOT FIND ANY ISSUES. 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 A PRISM 6 CHANNEL ANALYZER, LIST NUMBER 06A36 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE ABBOTT PRISM HIV AG/AB COMBO ASSAY AND THE PRISM REACTION TRAYS ON THE PRISM ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: INITIAL 3.23, RETESTS: 12.88 AND 0.10 S/CO. THE SPECIMEN WAS P24 AND (B)(6) WHEN TESTED USING THE GENIUS METHOD. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721835 PRISM 6 CHANNEL ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MZA ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1