BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2214590 · Received August 10, 2011

    Report

    Report Number
    2183996-2011-02218
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 9, 2011
    Report Date
    August 4, 2011
    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

    MOTHER REPORTED THE BOLUS DELIVERY OF THE INFUSION DEVICE IS FAULTY. BLOOD GLUCOSE WAS 306 MG/DL ON (B)(6) 2011 AT 8:55 A.M., AND MOTHER ADMINISTERED 1.5 IU VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 532 MG/DL AT 11:40 A.M., AND MOTHER ADMINISTERED 2.5 IU VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 572 MG/DL AT 12:40 P.M., AND MOTHER ADMINISTERED 3.6 IU VIA THE INFUSION DEVICE AND PT ATE 4.8 KE. MOTHER CHANGED THE INFUSION SET, AND BLOOD GLUCOSE WAS 252 MG/DL AT 2:40 P.M. AND 373 MG/DL AT 6:00 P.M. PT ATE 4 KE AND MOTHER ADMINISTERED 2 IU AND 3 IU VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 510 MG/DL AT 7:30 P.M. BLOOD GLUCOSE ELEVATED ABOVE 600 MG/DL ON (B)(6) 2011, AND PT EXPERIENCED AN INCREASED URGE TO URINATE. MOTHER CALLED DIET COUNSELOR AND ADMINISTERED INSULIN VIA PEN. BLOOD GLUCOSE WAS 91 MG/DL AT 7:30 P.M. INSULIN CARTRIDGES ARE NOT REUSED AND ARE CHANGED EVERY 7 DAYS. INFUSION SET IS CHANGED EVERY 2-3 DAYS. PT DID NOT HAVE AN INFECTION OR START NEW MEDICATION. NORMAL BLOOD GLUCOSE IS 160-180 MG/DL. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. CORRECT TYPE OF BATTERY WAS USED IN THE INFUSION DEVICE, AND THE BATTERY SETTING WAS PROGRAMMED CORRECTLY. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO ADD'L INFO WAS PROVIDED.

    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 6 YR Required Intervention INSULIN INFUSION SET| INSULIN