BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3092128 · Received May 3, 2013

    Report

    Report Number
    2183996-2013-00781
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 30, 2012
    Report Date
    July 26, 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 TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. BASED ON THE HISTORY ANALYSIS THE PUMP DID NOT HAVE HIGH POWER CONSUMPTION. THE ADAPTER AND BATTERY COVER PASSED THE OPTICAL INSPECTION. THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK AND GLIDE FORCE TESTED. CARTRIDGE PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED INFUSION SET, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE HAS NOT CORRECTLY PROVIDED W2 BATTERY LOW WARNINGS FOR 1 YEAR, AND THE BATTERY LIFETIME IS OCCASIONALLY 2 WEEKS. SHE HAS EXPERIENCED HYPERGLYCEMIA IN RELATION TO THIS EVENT. HER BLOOD GLUCOSE ELEVATED TO 375 MG/DL TWO TIMES FROM (B)(6) 2013. SHE DELIVERED INSULIN VIA PEN AS TREATMENT AND CHANGED THE BATTERY IN THE INFUSION DEVICE. HER BLOOD GLUCOSE RETURNED TO A NORMAL LEVEL A SHORT TIME LATER, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194626 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR