BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3251482 · Received July 29, 2013

    Report

    Report Number
    2183996-2013-01411
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 11, 2013
    Report Date
    September 25, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ALARM FUNCTION OF THE INSULIN PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE 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 THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AS HIGH AS 500 MG/DL OVER THE PAST FIVE WEEKS. CORRECTION BOLUSES WITH THE INFUSION DEVICE WERE NOT SUCCESSFUL, BUT CORRECTION WITH INSULIN INJECTIONS WAS SUCCESSFUL. ON (B)(6) 2013 SHE RECEIVED STATIONARY TREATMENT AT THE HOSPITAL FOR ELEVATED BLOOD GLUCOSE LEVELS. THE PATIENT WAS SWITCHED TO HER BACKUP INFUSION DEVICE AND HER BLOOD GLUCOSE LEVELS RETURNED TO NORMAL. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352968 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 004 YR Hospitalization NOVO RAPID