BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2180319 · Received July 27, 2011

    Report

    Report Number
    2531779-2011-05305
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 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 NOTED IN THE PUMP HISTORY THAT WOULD INDICATE A PUMP MALFUNCTION. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES OCCURRING. THERE WERE NO DEFECTS FOUND ON INVESTIGATION. 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.

    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. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 WITH ELEVATED BLOOD GLUCOSE LEVELS, KETONES AND DEHYDRATION. THE PATIENT REPORTEDLY HAD ELEVATED BLOOD GLUCOSE LEVELS (370 - 474 MG/DL) BEGINNING ON (B)(6) 2011. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 WITH A BLOOD GLUCOSE LEVEL OF 210 MG/DL. THE PATIENT REMAINED ON THE PUMP AND CONTINUED TO USE IT WHILE IN THE HOSPITAL. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT DID NOT EAT REGULARLY OVER (B)(6). IT WAS REPORTED THAT THE PATIENT INCREASES HIS BASAL RATE ON HIS OWN. THERE WERE NO RECENT ALARMS FOUND IN THE PUMP HISTORY; BOLUS AND BASAL HISTORY WERE CONFIRMED TO BE CORRECT; THE PUMP HAS NOT BEEN SUSPENDED AND THE TOTAL DAILY DOSE OF INSULIN ADDS UP CORRECTLY.

    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 16 YR Hospitalization