BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2143483 · Received June 2, 2011

    Report

    Report Number
    2183996-2011-01546
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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

    THE PT REPORTED THE INFUSION DEVICE DISPLAYS E4 (OCCLUSION) ERROR, THE VIBRATION ALARM MAKES "STRONG" NOISES, AND SHE BELIEVES THE DEVICE DELIVERS TOO LITTLE INSULIN. ON (B)(6) 2011, E4 WAS DISPLAYED AND THE PT CHANGED THE INFUSION SITE AND TUBING. HER BLOOD GLUCOSE MEASURED 24 MMOL/L (432 MG/DL) AND SHE INJECTED INSULIN VIA SYRINGE. AT 7:00PM HER BLOOD GLUCOSE MEASURED 3.1 MMOL/L (56 MG/DL) AND SHE ATE 2 BE. AT 11:00PM HER BLOOD GLUCOSE MEASURED 8 MMOL/L (144 MG/DL). ON (B)(6) 2011 AT 2:30AM, THE PT WOKE UP AND SHE WAS SWEATING HEAVILY. HER BLOOD GLUCOSE MEASURED 21 MMOL/L (378 MG/DL) AND SHE INJECTED INSULIN VIA PEN. AT 7:00AM, HER BLOOD GLUCOSE MEASURED 3.1 MMOL/L (56 MG/DL). SHE STATED SHE CHANGES THE INFUSION SITE EVERY 2-3 DAYS AND THE INFUSION TUBING EVERY 12 DAYS. SHE WAS ADVISED TO REFER TO THE USER'S MANUAL. SHE CHANGES THE INSULIN CARTRIDGE EVERY 6 DAYS. HER NORMAL BLOOD GLUCOSE RANGE IS 6-7 MMOL/L (108-126 MG/DL). THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INSULIN INFUSION SET| INSULIN