BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3250373 · Received July 26, 2013

    Report

    Report Number
    2183996-2013-01405
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 19, 2013
    Report Date
    August 23, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC
    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

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTS MEET THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT PUMP: 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. E4 WERE FOUND IN THE HISTORY. THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY. HISTORY LIST: IN THE COMPLETE EVENT HISTORY THERE ARE ONLY TWO E4. NO UNUSUALLY EVENTS COULD BE OBSERVED ON THE EVENT HISTORY OF THE PUMP. ADAPTER/ BATTERY COVER: THE ADAPTER PASSED THE OPTICAL INSPECTION. THE BATTERY COVER PASSED THE OPTICAL INSPECTION. CARTRIDGE: 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. NO LOT NUMBER IS KNOWN THEREFORE, NO RETAIN SAMPLE COULD BE INVESTIGATED. INFUSION SET: SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE THE COMPLAINT CANNOT BE VERIFIED. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS FOR 2 WEEKS. PATIENT STATED HER BLOOD GLUCOSE LEVEL WENT UP TO 26 MMOL/L (468 MG/DL), TOOK CORRECTION VIA PEN AND THE INFUSION DEVICE AND INCREASED BASAL RATE UP TO 130%. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT REPORTED SHE THINKS THE INFUSION DEVICE DELIVERS TOO LOW INSULIN. PATIENT STATED THE INFUSION DEVICE OFTEN TRIGGERED AN E4 (OCCLUSION) ERROR MESSAGE. PATIENT REPORTED THAT ON (B)(6) 2013 AROUND 1 PM HER BLOOD GLUCOSE LEVEL WAS 16 MMOL/L (288 MG/DL). PATIENT STATED SHE WENT TO HER DIABETES SPECIALIST AND TALKED REGARDING THE ELEVATED BLOOD GLUCOSE VALUES. PATIENT REPORTED SHE RECEIVED NO MEDICAL OR OTHER TREATMENT BY THE DIABETES SPECIALIST. PATIENT DISCARDED THE ACCESSORIES. NO FURTHER INFORMATION IS AVAILABLE. 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
    350975 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR