BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER

    MDR report key: 2211442 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05874
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    September 9, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: IR1200/IR1250/2020/OTP BATTERY CAP. COMMON DEVICE NAME: BATTERY CAP. MODEL #: IR1200/IR1250/2020/OTP. (B)(6). CUSTOMER SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND DETERMINED THAT THE BATTERY CAP WAS DAMAGED. THE ALLEGED MALFUNCTION IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. THE ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. THE FAMILY MEMBER WAS ADVISED TO TAKE THE PATIENT OFF THE PUMP AND USE A BACK UP PLAN. THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT IN (B)(6) 2010 THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) AROUND 500 MG/DL AND WAS TAKEN TO THE HOSPITAL. SHE STATED THAT THERE WAS NO REASON FOUND FOR THE ELEVATED BG, BUT SHE BELIEVED IT MAY HAVE BEEN DUE TO THE BATTERY CAP NOT SECURING TO THE PUMP BECAUSE OF STRIPPED THREADS. THE FAMILY MEMBER DENIED ANY SITE/SET ISSUES. CUSTOMER SUPPORT ADVISED THE FAMILY MEMBER TO PUT THE PATIENT ON A BACK-UP PLAN UNTIL THE BATTERY CAP COULD BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTHER INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR