BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK SPIRIT COMBO

    MDR report key: 2202488 · Received August 5, 2011

    Report

    Report Number
    2183996-2011-02188
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 1, 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

    THE PT'S MOTHER REPORTED THE INFUSION DEVICE DOES NOT PROPERLY DISPLAY E4 (OCCLUSION) ERROR. SHE STATED THAT SHE DID NOT SEE A VISIBLE OCCLUSION OR LEAKAGE FROM THE INFUSION SET. SHE STATED THAT EITHER INSULIN WASN'T DELIVERED OR WAS DELIVERED INTERMITTENTLY. ON (B)(6) 2011, THE PT'S BLOOD GLUCOSE RANGED FROM 172-329 MG/DL FROM 12 PM TO 8:45 PM DESPITE BOLUSING THROUGH THE INFUSION DEVICE AND CHANGING THE INFUSION SET. AT 10:30 PM, THE PT'S BLOOD GLUCOSE MEASURED 34 MG/DL AND 149 MG/DL AT 11 PM. ON (B)(6) 2011, THE PT'S BLOOD GLUCOSE MEASURED 49 MG/DL AT 1:30 AM AND THE PT WAS CRAMPED AND UNCONSCIOUS. THE MOTHER INJECTED THE PT WITH GLUCAGON AND AFTER THIS THE PT VOMITED. AT 2 PM, THE PT'S BLOOD GLUCOSE MEASURED 73 MG/DL AND AT 2:05 AM HER BLOOD GLUCOSE MEASURE 95 MG/DL AND SHE WAS RESPONSIVE. THE MOTHER CONTACTED THE EMERGENCY DR AND THE PT WAS TRANSPORTED TO THE HOSP. HER BLOOD GLUCOSE RANGED FROM 157 MG/DL AT 2:20 AM TO 265 MG/DL AT 4 AM. THE PT WAS TREATED WITH A SALINE IV AND ELECTROLYTES. AT 5:20 AM, HER BLOOD GLUCOSE MEASURED 230 MG/DL, 163 MG/DL AT 7 AM, AND 192 MG/DL AT 8 AM. THE PT ATE 1/2 BE AND BOLUSED 1.4 UNITS VIA THE INFUSION DEVICE. AT 9 AM, HER BLOOD GLUCOSE MEASURED 197 MG/DL AND SHE BOLUSED 0.3 UNITS THROUGH THE INFUSION DEVICE. SHE WAS DISCHARGED FROM THE HOSP AT 2 PM. THE PT'S NORMAL BLOOD GLUCOSE RANGE IS 110-130 MG/DL. 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-CHECK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R INSULIN INFUSION SET| INSULIN