BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM NEXT ANALYZER

    MDR report key: 5220903 · Received November 12, 2015

    Report

    Report Number
    1628664-2015-00283
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    October 14, 2015
    Report Date
    November 20, 2015
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZA
    PMA / PMN Number
    BK970042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TECHNICIAN RECEIVED MEDICATION 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

    EVALUATION OF THE ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A DESIGN HISTORY REVIEW AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. A DESIGN HISTORY REVIEW CONCLUDED THAT HAZARDS HAVE BEEN SUFFICIENTLY ADDRESSED WITH RESPECT TO THIS EVENT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE ABBOTT PRISM NEXT ANALYZER, LIST NUMBER (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN WAS SPLASHED IN THE EYE WITH LIQUID WHILE EMPTYING TRAY WASTE FROM THE PRISM 6 CHANNEL-CE ANALYZER. IT WAS INDICATED THAT THE TECHNICIAN FLUSHED HER EYES WITH WATER, AFTER REMOVING HER GOGGLES AND CONTACTS, FOR 10 MINUTES. THE TECHNICIAN RECEIVED TREATMENT AT THE URGENT CARE FACILITY (CONCENTRA). SHE WAS PRESCRIBED ISENTRESS AND TRUVADA, BOTH ANTI-VIRAL MEDICATIONS. NO INFORMATION HAS BEEN PROVIDED REGARDING ANY AFFECTS FROM THE MEDICATION. THE CUSTOMER RELAYED THAT THE TECHNICIAN HAD AN UPSET STOMACH ON ONE DAY AFTER TAKING THE ISENTRESS MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751285 PRISM NEXT ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MZA ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention