BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUALICHECK, LEVEL 1

    MDR report key: 3050263 · Received April 5, 2013

    Report

    Report Number
    3002807968-2013-00007
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 6, 2013
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    GIO
    PMA / PMN Number
    K130415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION OF THE DEVICE IN QUESTION WAS PERFORMED.

    Description of Event or Problem · 1

    NO PATIENT WAS INVOLVED IN THIS EVENT. THIS EVENT CONCERNS A USER ERROR WHERE A NURSE HURT HERSELF WHEN OPENING A GLASS AMPOULE. THE NURSE DID NOT USE THE RECOMMENDED AMPOULE OPENER (920-712) WHEN SHE OPENED A QUALICHECK LEVEL 1 AMPOULE. THE BREAK WAS UNEVEN AND LEFT A SHARP POINT WHICH PUNCTURED HER GLOVE AND CUT HER LEFT THUMB. IT IS RECOMMENDED TO USE THE AMPOULE OPENER WHEN OPENING QUALICHECK AMPOULES. WHEN BREAKING GLASS AMPOULES WITH THE HANDS, THERE IS AN INCREASED RISK OF HAND INJURY. ACCORDING TO THE SAFETY DATA SHEET THE POTENTIAL HAZARDS OF THE PRODUCT ARE CONSIDERED TO BE LIMITED. THE PRODUCT DOES, HOWEVER, CONTAIN A SMALL QUANTITY OF AN ALLERGENIC ADDITIVE WHICH CAN, IN DISPOSED INDIVIDUALS, CAUSE AN ALLERGIC REACTION. THE NURSE HAS REPORTED THAT SHE HAS NOT EXPERIENCED ANY ILL EFFECTS FROM THE INCIDENT. SHE HAS ALSO NOW BEEN PROVIDED WITH AN AMPOULE OPENER FOR FUTURE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139736 QUALICHECK, LEVEL 1 S7570 HIGH METABOLIC QC SOLUTION GIO RADIOMETER MEDICAL APS

    Patients

    Seq Age Sex Outcome Treatment
    1