BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2161961 · Received April 20, 2011

    Report

    Report Number
    2531779-2011-02751
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 PATIENT'S WIFE, ALLEGED THAT THE PATIENT'S PUMP HAD NOT DELIVERED INSULIN ACCURATELY AND REPORTED THAT THE PATIENT HAD HIGH AND LOW BLOOD GLUCOSE LEVELS AFTERWARDS. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 34 MG/DL, AND EXPERIENCED THE SYMPTOMS OF DIZZINESS AND DISORIENTATION. ON (B)(6) 2011 AT 7:56 AM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 38 MG/DL. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING CARBOHYDRATES. ONE HOUR AFTER TAKING HIS BREAKFAST BOLUS, THE PATIENT'S BLOOD GLUCOSE READING WAS 60 MG/DL. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. IT WAS ALSO REPORTED THAT THE KEYPAD BUTTONS HAD TO BE PRESSED MULTIPLE TIMES IN ORDER TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE KEYPAD IS REPORTEDLY INTACT AND THE PUMP HAS NOT BEEN EXPOSED TO MOISTURE. TROUBLESHOOTING REVEALED THE PATIENT'S TECHNIQUE WAS CORRECT AND THERE WERE NO ISSUES WITH THE INFUSION SITE. A REVIEW OF THE PUMP HISTORY REVEALED ALL BASAL AND BOLUS DOSES HAD BEEN DELIVERED ACCURATELY AND MATCHED THOSE PROGRAMMED INTO THE PUMP. IT WAS DETERMINED DURING TROUBLESHOOTING THAT THE PUMP HAD BEEN EXPOSED TO X-RAYS MULTIPLE TIMES. THE MANUFACTURER RECOMMENDS THE PUMP NEVER BE EXPOSED TO CT, X-RAY OR MRI SCANS. THE REPORTER ALSO STATED THAT TWO TO THREE YEARS AGO, THE PATIENT WAS FOUND UNCONSCIOUS, PARAMEDICS WERE CONTACTED, AND HE RECEIVED TREATMENT WITH GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R