BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2991021 · Received March 6, 2013

    Report

    Report Number
    2531779-2013-02408
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. THE ALARM HISTORY SHOWS NO ALARMS ON THE DATE OF THE EVENT. THE RECORDED BOLUSES AND THE PROGRAMMED BASAL RATES, LEADING UP TO THE DATE OF THE EVENT, ADD UP CORRECTLY TO EQUAL THE TOTAL DAILY INSULIN TOTALS. A 29 HOUR FLOW ACCURACY TEST WAS COMPLETED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A FORCE SENSOR CALIBRATION CHECK SHOWED THE PUMP IS NOT DETECTING THE CORRECT FORCE AT 5 LBS. THE FORCE SENSOR RESISTANCE WAS FOUND TO BE IN SPECIFICATION. THE LAST BASAL DELIVERY WAS ON (B)(4) 2013 AND THE LAST BOLUS WAS RECORDED ON (B)(4) 2013. THE EVENT OCCURRED ON (B)(4) 2013, THE BLACK BOX FOR THIS DATE HAS BEEN OVERWRITTEN. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT ON (B)(6) 2013, SHE EXPERIENCED A BLOOD GLUCOSE (BG) VALUE OF 2.0MMOL/L AND LOST CONSCIOUSNESS. THE PATIENT REPORTEDLY WAS TREATED VIA GLUCAGON INJECTION AND THE PATIENT'S BG REPORTEDLY ELEVATED TO 3.5MMOL/L AND THEN ELEVATED AGAIN TO 9.8 MMOL/L WHEN THE PATIENT HAD ORAL CARBOHYDRATES. THE PATIENT REPORTEDLY DID NOT REQUIRE MEDICAL INTERVENTION. IT WAS NOTED THAT AFTER THE PUMP'S SETTINGS WERE ADJUSTED BY THE NURSE EDUCATOR, THE PATIENT DID NOT HAVE ANY MORE HYPOGLYCEMIC EVENTS. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND THERE WERE NO ISSUES NOTED WITH THE PROGRAMMING/SETTINGS ON THE PUMP. THERE WERE NO ISSUES NOTED WITH THE SITE/SET OR CARTRIDGE. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. IT WAS NOTED THAT THE PATIENT AND THE NURSE EDUCATOR BELIEVED THAT SINCE THE PATIENT WAS UNDER A LOT OF STRESS AND THAT THIS MAY HAVE BEEN A CONTRIBUTOR TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94938 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening