BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISM 6 CHANNEL ANALYZER

    MDR report key: 8060205 · Received November 12, 2018

    Report

    Report Number
    1628664-2018-02004
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZA
    PMA / PMN Number
    BK970042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE AND THE ABBOTT PRISM OPERATIONS MANUAL NOTES CAUTION AND WARNING ASSOCIATED WITH PHYSICAL HAZARDS AND EXPLAINS THE SAFETY ICONS WHICH ARE PRESENT ON THE ABBOTT PRISM SYSTEM. THE ISSUE WAS RESOLVED BY REATTACHING THE BRACKET AND BASE PLATE (ABBOTT PRISM WASTE CART TRAY, PART NUMBER 1-52433-01). THE BASE PLATE IS ATTACHED TO THE PRISM INSTRUMENT VIA A MAGNETIC BRACKET. THIS BRACKET HAD BECOME LOOSE AND FALLEN OFF CAUSING THE BASE PLATE TO MOVE WHEN THE WASTE CART WAS BEING TAKEN IN AND OUT OF THE INSTRUMENT. THE BRACKET SLOTS ONTO THE UNDERNEATH OF THE PRISM FRAME BY 4 BOLTS. THESE BOLTS HAD BECOME LOOSE AND THE BRACKET FELL OFF. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    A STAFF MEMBER AT MANCHESTER BLOOD TRANSFUSION SERVICES INJURED THEIR BACK WHILE OPERATING THE PRISM ANALYZER. THE STAFF MEMBER SUFFERED A MUSCULAR BACK INJURY. THE PATIENT IS NO LONGER IN PAIN, BUT IS A LITTLE STIFF AROUND THE INJURED AREA. THE STAFF MEMBER DID NOT SEE A DOCTOR, THEY TOOK IBUPROFEN TO HELP WITH THE PAIN AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899920 PRISM 6 CHANNEL ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MZA ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability