BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3062534 · Received April 17, 2013

    Report

    Report Number
    2183996-2013-00688
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    April 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSIS TEST AND MEETS THE SPECIFICATION. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFUL AND NO MALFUNCTION COULD BE OBSERVED DURING THE IU INVESTIGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. HISTORY LIST: NOTHING UNUSUAL WAS FOUND IN THE HISTORY LIST. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    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 OF UP TO 31 MMOL/L (558 MG/DL) FOR 2WEEKS. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL THIS MORNING WAS 7.5 MMOL/L (135 MG/DL), SHE BOLUSED WITH THE INFUSION DEVICE AND HAD BREAKFAST. PATIENT STATED HER BLOOD GLUCOSE LEVEL AT 9:30 AM WAS 25.5 MMOL/L (459 MG/DL). SHE CHANGED THE INFUSION SET AND TOOK A BOLUS OF 15 UNITS OF INSULIN VIA THE INFUSION DEVICE. PATIENT REPORTED THAT AT 10:30 AM HER BLOOD GLUCOSE LEVEL WAS 31.0 MMOL/L (558 MG/DL), SHE TOOK CORRECTION VIA PEN; WAS SUCCESSFUL. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166277 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 041 YR