BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1992993 · Received February 7, 2011

    Report

    Report Number
    2531779-2011-00696
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 9, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    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 FILED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE RPTR CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PT) AND REPORTED ELEVATED BLOOD GLUCOSE LEVELS. THE RPTR INDICATED THAT THE PT'S BLOOD GLUCOSE (BG) LEVEL HAD BEEN IN THE "300'S" MG/DL ALL DAY. SHE ALSO MENTIONED THAT THE PT HAD A STOMACH ACHE AND WAS VOMITING. AT THE TIME OF THE CALL WITH ANIMAS, THE RPTR CLAIMED THAT THE PT'S BLOOD GLUCOSE LEVEL WAS "511 MG/DL." BOLUSES WERE CONFIRMED IN THE PUMP'S HISTORY. THE PUMP'S DATE/TIME AND BASAL RATES WERE ALSO CONFIRMED. THE PUMP WAS PRIMED. NO INADVERTENT SUSPENDS WERE NOTED. THE RPTR DENIED ANY KINKING, AIR BUBBLES, OR BLOOD NOTED AT THE SITE. THE PT REPORTEDLY DID NOT HAVE ANY SITE ISSUES. THE RPTR CLAIMED THAT THE PT WAS RESPONDING TO BOLUSES BUT WAS NOT GOING BELOW "200 MG/DL." BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE RPTR CLAIMED THAT THE PT DEVELOPED AN ELEVATED BLOOD GLUCOSE LEVEL THAT MEETS ANIMAS' CRITERIA FOR A SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening