BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 2992000 · Received March 7, 2013

    Report

    Report Number
    2183996-2013-00328
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    August 28, 2012
    Report Date
    May 22, 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

    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 CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. 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 WITHIN THE ALARM FUNCTION 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. NOTHING UNUSUAL WAS FOUND IN THE PUMP HISTORY.

    Description of Event or Problem · 1

    PATIENT HAS EXPERIENCED HYPERGLYCEMIA OF APPROXIMATELY 300 MG/DL FOR THE PAST 6 MONTHS WHILE USING THE INFUSION DEVICE. INSULIN IS DELIVERED VIA THE INFUSION DEVICE TO CORRECT HYPERGLYCEMIA. ON (B)(6) 2013, A TEACHER CALLED PATIENT'S GRANDMOTHER AND REPORTED BLOOD GLUCOSE WAS ELEVATED TO "HI." PATIENT WAS APPROACHABLE BUT HYPERACTIVE. PATIENT CHANGED TO THE BACKUP INFUSION DEVICE AT 6:00 P.M. USING THE SAME BASAL RATES, AND BLOOD GLUCOSE WAS "OK" AT THE TIME OF THE REPORT. GRANDMOTHER REPORTED THE INFUSION DEVICE HAS NEVER GIVEN A LOW/EMPTY CARTRIDGE OR BATTERY ERROR. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. THE PATIENT 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
    96790 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 010 YR