BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2221303 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06162
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    July 26, 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

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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: A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ALARMS OR CONDITIONS THAT WOULD INDICATE A PUMP MALFUNCTION NOTED IN THE PUMP HISTORY. A REVIEW OF THE PUMP'S SUSPEND HISTORY INDICATED THAT THE PUMP WAS SUSPENDED AT 8:03 PM ON (B)(6) 2011; THE PUMP WAS RESUMED AT 8:03 PM THE SAME DATE, AND A 0.0 UNIT BOLUS WAS PROGRAMMED AT 8:04 PM ON THE SAME DATE. THE HISTORY INDICATED THAT THE PUMP WAS AGAIN SUSPENDED ON (B)(6) 2011 AT 8:15 PM, AND RESUMED AT 8:16 PM. A 0.0 UNIT BOLUS WAS PERFORMED AT 8:17 PM. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY.

    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

    FOR AN UNSPECIFIED TIME PERIOD, IT WAS REPORTED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS RANGING FROM 500 MG/DL TO 600 MG/DL. THE PATIENT WAS POSITIVE FOR KETONES, AND EXPERIENCED THE SYMPTOMS OF LETHARGY AND THIRST. THE PATIENT CORRECTED HER BLOOD GLUCOSE LEVELS WITH INSULIN VIA A SYRINGE. THE PATIENT DID NOT SEEK MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PUMP'S DATE/TIME WERE CORRECT, ALL SETTINGS WERE CORRECT, AND THE BASAL SETTINGS WERE CORRECT. IT WAS ALSO DETERMINED THE PATIENT'S TECHNIQUE OF INSERTING THE INFUSION SET WAS INCORRECT RESULTING IN BENT CANNULAS. THE PATIENT'S TECHNIQUE WAS INCORRECT AND THERE WERE BENT CANNULAS IN THE INFUSION SETS, WHICH MAY HAVE CONTRIBUTED TO INCORRECT INSULIN INFUSION. HOWEVER, AS THE PATIENT SUFFERED SYMPTOMS AND BLOOD GLUCOSE LEVELS INDICATIVE OF SEVERE HYPERGLYCEMIA, 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 49 YR Life Threatening