BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2241608 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06684
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEWED OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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. THIS REPORT IS MADE 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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DIRECTLY FROM HER DOCTOR'S OFFICE ON (B)(6) 2011. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 200MG/DL ON THE NIGHT OF (B)(6) 2011, AND ROSE TO 333MG/DL ON THE MORNING OF (B)(6). THE PATIENT GAVE A CORRECTION BOLUS AND 1 HOUR LATER HER BLOOD GLUCOSE LEVEL WAS 332MG/DL. THE PATIENT BEGAN VOMITING AND WAS TAKEN TO HER DOCTOR'S OFFICE, AND THEN ADMITTED TO THE HOSPITAL WITH DKA. THE INFUSION SET WAS REMOVED AND THE PATIENT'S MOTHER INDICATED THAT THE CANNULA APPEARED TO BE SLIGHTLY CRIMPED. THE PATIENT'S MOTHER CALLED BACK AND TROUBLESHOOTING WAS PERFORMED AND THERE IS NO INDICATION OF A MALFUNCTION OF THE PUMP. THE PATIENT'S PHYSICIAN DOES NOT BELIEVE THAT THE PUMP IS OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR