BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3082833 · Received April 29, 2013

    Report

    Report Number
    2183996-2013-00757
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 21, 2013
    Report Date
    July 31, 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 DUE TO MISHANDLING THE PRODUCT. RESULT INFUSION SET: THE USED RETURNED SAMPLES (ONE USED CANNULA AND ONE USED TRANSFER SET) WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. ALL TEST RESULTS OF THE TRANSFER SET WERE WITHIN SPECIFICATIONS. AN OCCLUSION WAS FOUND IN THE INJECTION NEEDLE OF THE CANNULA. THE MANUFACTURER TESTS ALL PRODUCTS DURING PRODUCTION FOR LEAK AND FLOW. THERE IS NO INDICATION THAT A NONSPECIFIC PRODUCT HAS BEEN DELIVERED TO ANY CUSTOMER. 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. HISTORY LIST: 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. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    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 ERRATIC BLOOD GLUCOSE LEVELS LATELY. PATIENT STATED THE FIRST INCIDENT OCCURRED ON (B)(6) 2013 WITH A BLOOD GLUCOSE LEVEL OF 380 MG/DL WHICH IS THE HIGHEST VALUE. PATIENT REPORTED ON MONDAY, THE DAILY TOTAL OF INSULIN WAS RAISED TO 60% ABOVE THE REGULAR AMOUNT OF INSULIN IN SPITE OF HER EATING LESS. PATIENT STATED THE LOWEST BLOOD GLUCOSE LEVEL SHE EXPERIENCED WAS 36 MG/DL ON (B)(6) 2013. PATIENT REPORTED THE DOCTOR COMPLAINED THAT THE INFUSION DEVICE DOES NOT DELIVER INSULIN CORRECTLY; SOMETIMES TOO HIGH AND SOMETIMES TOO LOW. PATIENT REPORTED SHE DID NOT NEED ANY OUTSIDE ASSISTANCE. 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 AND ACCESSORIES FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185622 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR