BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRONPLUS

    MDR report key: 1893652 · Received November 4, 2010

    Report

    Report Number
    2183996-2010-02231
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED FEELING SICK ON (B)(6) 2010 AND THROWING UP. PT STATED, THE DOCTOR VISITED HER AND GAVE HER MEDICATIONS FOR NAUSEA. PT REPORTED ON (B)(6) 2010 AT 4:15 AM, THE EMERGENCY MEDICAL TECHS DROVE HER TO THE HOSPITAL. PT STATED AT THE HOSPITAL HER BLOOD GLUCOSE LEVEL WAS 1000 MG/DL. PT REPORTED, SHE WAS CONSCIOUS WHILE AT HOME, BUT ON THE WAY TO THE HOSPITAL EMERGENCY ROOM, SHE WAS UNCONSCIOUS FOR APPROX 20 MINS. THE PT'S DOCTOR REPORTED, THE PT STATED THAT BOTH OF HER INFUSION DEVICES AND THE METER WERE DEFECTIVE. PT STATED AT THIS TIME BOTH INFUSION DEVICES SHOWS AN E2 (POWERPACK DEPLETED) OR AN A2 (LOW POWERPACK WARNING). PT REPORTED, SHE CHANGED THE BATTERY POWERPACK OFTEN. PT'S NORMAL BLOOD GLUCOSE LEVEL IS UNK. PT'S DOCTOR REPORTED, THE PT WAS IN THE HOSPITAL ON (B)(6) 2010 FOR HYPOGLYCEMIA BUT WENT HOME AFTER THERAPY. PT REPORTED, SHE IS CURRENTLY BEEN IN THE HOSPITAL. ON F/U CALL TO PT ON (B)(6) 2010, PT STATED, SHE WAS IN THE HOSPITAL FROM (B)(6) 2010-(B)(6) 2010. NO FURTHER INFO IS AVAILABLE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK D-TRONPLUS INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN: (B)(6)| INSULIN INFUSION SET: (B)(6)