BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2042165 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02034
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE REPORTER, THE PT'S MOTHER, REPORTED THAT ON (B)(6), 2011 AT 4:15 PM THE PT REC'D A BOLUS DOSE OF 0.7 UNITS INSULIN WITHOUT USER INTERVENTION. THE REPORTER DENIED THAT THE PT HAD USED THE METER REMOTE TO GIVE HIMSELF THE BOLUS. THE PT HAD OBTAINED BLOOD GLUCOSE READINGS RANGING FROM 40 MG/DL TO 50 MG/DL ON AN UNSPECIFIED DATE. THE PT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND DID NOT SEEK MEDICAL ATTENTION. THE PT ADMINISTERED SELF-TREATMENT WITH JUICE TO RAISE HIS BLOOD GLUCOSE LEVELS. TROUBLESHOOTING REVEALED THE BASAL RATES ARE PROGRAMMED CORRECTLY, AND THE PT'S TECHNIQUE WAS CORRECT.

    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 6 YR Life Threatening| R