BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3122762 · Received May 21, 2013

    Report

    Report Number
    2183996-2013-00899
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 16, 2013
    Report Date
    July 11, 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 CAN BE VERIFIED. RESULT ACCORDING TO THE PUMP HISTORY THE TIME/DATE SETTINGS HAVE BEEN LOST AFTER RESTART OF THE PUMP AFTER BATTERY CHANGE. THE ACID OF THE SUPERCAP HAS LEAKED OUT. THEREFORE THE SUPERCAP AND THE SURROUNDING ELECTRONIC PARTS ARE CORRODED. THE SUPERCAP WAS NOT FUNCTIONING ANYMORE AND DID NOT PROVIDE ENERGY DURING THE BATTERY CHANGE PROCESS TO KEEP THE DATE/TIME SETTINGS IN MEMORY. A SUPERCAP IS A CAPACITOR USED FOR PROVIDING ENERGY TO THE MEMORY INTEGRATED CIRCUIT TO KEEP THE DATE AND TIME SETTINGS FOR A WHILE, WHEN NO BATTERY IS IN THE PUMP. THE INSULIN PUMP CORRECTLY NOTIFIED THE USER TO CHECK THE DATE AND TIME SETTING AFTER RESTART AND THE ERROR E8 OCCURRED. 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: AT (B)(6) 2012 10:05 CUSTOMER PROGRAMMED A BOLUS OF 12.5 IU AND THE PUMP SHUT DOWN BY A SHORT CIRCUIT (DAMAGED SUPERCAP). A FEW SECONDS LATER HE GOT A W8 (BOLUS ABORTED), AFTERWARDS E8 (POWER DOWN) AND THE PUMP LOST TIME AND DATE. THE ERROR AND THE WARNING WERE QUIT BY THE USER. NO E2, W2 OR E7 FOUND.

    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 PROGRAMMING A 12.0 UNIT BOLUS OF INSULIN ON (B)(6) 2013 AT APPROXIMATELY 10:05 AM AND PLACED IT IN THE POCKET. PATIENT REPORTED HEARING 2 BEEPS AND WHEN CHECKING THE INFUSION DEVICE, NOTICED THE DEVICE HAD POWERED OFF. PATIENT REPORTED MISSING ALERTS AND ERRORS; W2 (BATTERY LOW), E2 (BATTERY DEPLETED), AND E7 (ELECTRONIC ERROR) MESSAGE. PATIENT REPORTED CHANGING THE BATTERY AND NOTICED THAT THE TIME/DATE SETTING WAS LOST. PATIENT REPORTS THE INFUSION DEVICE SHOWS AN E8 (POWER INTERRUPT) AND W8 (BOLUS CANCELLED). PATIENT REPORTED A BLOOD GLUCOSE LEVEL OF 324 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT WAS ABLE TO GET BLOOD GLUCOSE LEVEL UNDER CONTROL. 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
    224916 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 017 YR