BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3102817 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00813
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 22, 2013
    Report Date
    August 23, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS RESULT AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. AS THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS RESULTING IN KETONES. PATIENT STATED HER ELEVATED BLOOD GLUCOSE LEVEL IS CAUSE BY HER INFUSION DEVICE HAVING NO POWER AND THEREFORE NOT DELIVERING INSULIN. PATIENT REPORTED THAT AT APPROXIMATELY 2 AM (EXACT TIME COULD NOT BE GIVEN) SHE PERFORMED A BATTERY CHANGED AND THINKS SHE MAY HAVE INSERTED THE BATTERY THE WRONG WAY AND THEN OVER TIGHTENED THE BATTERY COVER. PATIENT STATED SHE WAS UNABLE TO REMOVE THE BATTERY AND THE INFUSION DEVICE HAD NO POWER. PATIENT REPORTED SHE DID NOT GO ON A BACKUP PLAN AND SO HAD NO INSULIN BEING DELIVERED. PATIENT STATED SHE TESTED HER BLOOD GLUCOSE LEVEL AT APPROXIMATELY 7 AM (EXACT TIME COULD NOT BE GIVEN) WITH A READING OF 22.0 MMOL/L (396 MG/DL). PATIENT REPORTED SHE TOOK HERSELF TO THE LOCAL HOSPITAL DIABETES SERVICE AT APPROXIMATELY 7:30 AM WHERE IT WAS FOUND SHE HAD KETONES. PATIENT STATED SHE WAS TREATED BY HER DIABETES EDUCATOR WITH 6 UNITS OF LANTUS INSULIN VIA PEN. PATIENT REPORTED SHE WAS NOT ADMITTED TO THE HOSPITAL BUT IS BEING MONITORED BY HER DIABETES EDUCATOR UNTIL A REPLACEMENT INFUSION DEVICE IS RECEIVED. PATIENT STATED SHE HAD SYMPTOMS OF BEING THIRSTY, NAUSEA, AND FEELING TIRED. PATIENT REPORTED HER CONDITION IMPROVED BUT THE SYMPTOMS OF ELEVATED BLOOD GLUCOSE LEVEL REMAINS. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203906 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR Required Intervention