BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3040224 · Received April 8, 2013

    Report

    Report Number
    2183996-2013-00603
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. E7002 WERE FOUND IN THE HISTORY, AND THE VIBRATOR MOTOR DOES NOT FUNCTION. AN INTERNAL DEFECT OF THE VIBRATOR LED TO THE PROBLEM. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST 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. THE ALARM FUNCTIONS OF THE PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS.

    Description of Event or Problem · 1

    MOTHER REPORTED PATIENT EXPERIENCED HYPERGLYCEMIA OF 23.8 MMOL/L (428.4 MG/DL) AND KETONES OF 1.7 MMOL/L IN THE MORNING. SHE INJECTED 4 UNITS OF INSULIN, AND SHE WAITED 15 MINUTES, MEASURED HIS BLOOD GLUCOSE AGAIN, AND INJECTED MORE INSULIN (AMOUNT NOT PROVIDED). HIS BLOOD GLUCOSE RETURNED TO NORMAL AFTER 30 MINUTES. MOTHER REMOVED THE INFUSION DEVICE AND SAW INSULIN FLOW FROM THE CANNULA. SHE REPORTED E7 ELECTRONIC ERRORS HAVE APPEARED DURING THE LAST 4 CARTRIDGE/INFUSION SET CHANGES, AND SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143162 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 008 YR NOVO RAPID INSULIN