BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM 6 CHANNEL ANALYZER

    MDR report key: 5307150 · Received December 17, 2015

    Report

    Report Number
    1628664-2015-00332
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Report Date
    January 18, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZA
    PMA / PMN Number
    BK970042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(4). CONCOMITANT MEDICAL PRODUCTS: PRISM REACTION TRAYS LN 05A07-01 LOT 55001M500 PRISM (B)(6) REAGENTS LN 06A52-48 LOT 54292LI00 PRISM (B)(6) AG/AB COMBO REAGENTS LN 07G46-48 LOT 56728LI00.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRISM REACTION TRAYS LN 05A07-01, LOT 55001M500 PRISM (B)(4) REAGENTS LN 06A52-48, LOT 54292LI00 PRISM (B)(4) AG/AB COMBO REAGENTS LN 07G46-48, LOT 56728LI00. AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES, SPECIFICITY TESTING, A REVIEW OF LABELING, AND A REVIEW OF HISTORICAL RECORDS. EVALUATION OF COMPLAINT DATA FOR LOT 56728LI00 AND HISTORICAL COMPLAINT INFORMATION DID NOT IDENTIFY ANY ISSUES RELATED TO THE CUSTOMER'S OBSERVATION. A REVIEW OF THE DESIGN HISTORY RECORD WAS COMPLETED AND NO ISSUES WERE IDENTIFIED. A REVIEW OF LABELING WAS ALSO PERFORMED AND FOUND THAT ADEQUATE INFORMATION IS PROVIDED TO ADDRESS THE CUSTOMER'S ISSUE. A HUMAN NEGATIVE POPULATION PANEL CONSISTING OF 105 MEMBERS WAS TESTED USING PRISM (B)(4) AG/AB COMBO, LOT 56728LI00, WITH PRISM REACTION TRAYS, LOT 55001M500, AND THEY WERE ALL (B)(6). BASED ON ALL AVAILABLE INFORMATION AND THIS INVESTIGATION, THE PRISM (B)(4) AG/AB COMBO, LOT 56728LI00, WITH PRISM REACTION TRAYS, LOT 55001M500, PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. NO NEW PERFORMANCE ISSUES WERE IDENTIFIED AND FURTHER INVESTIGATION WAS NOT WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED MULTIPLE (B)(6) AG/AB COMBO RESULTS ON THE PRISM ANALYZER. THERE WAS NO IMPACT TO PATIENT OR DONOR MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834942 PRISM 6 CHANNEL ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MZA ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1