BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2042206 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02002
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: NO DATA WAS IN THE BLACK BOX OR DOWNLOAD HISTORIES FROM THE TIME OF THE REPORTED ERRATIC BGS DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE RPTR CLAIMED SHE HAD LOW BLOOD GLUCOSE RANGING FROM 40 TO 60 MG/DL WITH SYMPTOM OF "CONFUSION." AT THE TIME OF CONCERN, THE PT TOOK TREATMENT WITH CARBOHYDRATE. SUBSEQUENTLY THE PT'S BLOOD GLUCOSE WENT BACK UP. DURING TROUBLESHOOTING, THE ANIMAS HEALTHCARE REPRESENTATIVE NOTED THAT THE PT'S ACTIVITY LEVEL HAS BEEN CONSISTENT. HER BASAL RATE VARIES DEPENDING ON HER ACTIVITY LEVEL FOR THE DAY. THE ANIMAS INSULIN PUMP REPORTEDLY FUNCTIONED ACCORDINGLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED WAS HYPOGLYCEMIC AND RECEIVED MEDICAL INTERVENTION ACCORDINGLY WHILE USING THE ANIMAS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R