BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2032293 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01878
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. 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) 2011 WITH THE FOLLOWING FINDINGS: NO PUMP OR BLACK BOX HISTORY FROM THE TIME OF THE EVENT WAS AVAILABLE DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. 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

    THE REPORTER REPORTED THAT ON (B)(6), 2011, THE PT OBTAINED A BLOOD GLUCOSE READING OF 500MG/DL; SHE EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. EARLIER, THE PT HAD DISCONNECTED FROM THE PUMP, AND WAS CONFUSED AND UNABLE TO RELOAD AND PRIME THE INSULIN PUMP AND REINSERT THE INFUSION SET. THE PT CONTACTED HER HCP FOR ASSISTANCE/ADVICE; AND TOOK TEN UNITS INSULIN VIA A SYRINGE. THE PT'S BLOOD GLUCOSE READING WAS THEN 127 MG/DL. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE PT WAS ABLE TO RELOAD AND PRIME THE PUMP, AND TO SUCCESSFULLY REINSERT THE INFUSION SET. THERE IS NO EVIDENCE THE PUMP WAS NOT FUNCTIONING APPROPRIATELY. THE PT DISCONNECTED FROM THE PUMP, BECAME CONFUSED AND WAS UNABLE TO REINSERT THE INFUSION SET, HER BLOOD GLUCOSE LEVEL ROSE TO 500 MG/DL. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R