BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982060 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00174
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 27, 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
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    E7121 WERE FOUND IN THE HISTORY. THE E7121 IS A CONSEQUENCE FAILURE OF THE DEFECTIVE FORCE SENSOR. 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 FUNCTIONS OF THE PUMP WERE TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT THE PT THINKS HER INFUSION DEVICE DOES NOT DELIVER ENOUGH INSULIN. SHE STATED THAT EVERY TIME HER CARTRIDGE WAS NEARING EMPTY, HER BLOOD GLUCOSE WOULD ELEVATE. ON (B)(6) 2013, HER BLOOD GLUCOSE LEVEL WAS 185 MG/DL AND SHE PROGRAMMED A BOLUS BEFORE SHE WENT TO BED. THE FOLLOWING MORNING HER BLOOD GLUCOSE LEVEL WAS 342 MG/DL. THE PT CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND HER BLOOD GLUCOSE LEVEL RETURNED TO NORMAL. THE PT HAS FOLLOWED HER REFERENCE MATERIAL FOR CORRECTLY FILLING AND REPLACING THE INSULIN CARTRIDGE. SHE STATED THAT HER DEVICE HAS DISPLAYED E7 (ELECTRONIC ERROR). THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55356 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP