BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2071155 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02934
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A REVIEW OF THE PUMP HISTORY DID NOT SHOW ANY ALARMS OR CONDITIONS THAT WOULD INDICATE A PUMP MALFUNCTION. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES.

    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. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE REPORTER, THE PATIENT'S FATHER, REPORTED THAT IN (B)(6) 2011 THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 38 MG/DL. THE PATIENT EXPERIENCED THE SYMPTOM OF LOSS OF CONSCIOUSNESS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2011 WITH A DIAGNOSIS OF MENINGOCOCCUS ENTERITIS. WHILE HOSPITALIZED, THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN. THE PATIENT WAS RETURNED TO THE PUMP WHEN DISCHARGED FROM THE HOSPITAL. PRIOR TO THIS EVENT, THE PUMP BOLUS HISTORY REVEALED THE BOLUS DOSES WERE AS EXPECTED AND THERE WERE NO ALARMS IN THE PUMP HISTORY. THERE IS NO EVIDENCE THE INSULIN PUMP WAS NOT FUNCTIONING APPROPRIATELY IN DELIVERING ACCURATE DOSES OF INSULIN. HOWEVER, AS THE PATIENT EXPERIENCED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| L