BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3203583 · Received July 3, 2013

    Report

    Report Number
    2531779-2013-09559
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: REVIEW OF THE BLACK BOX RECORDS SHOWED A 2 HOUR BASAL DELIVERY INTERRUPTION ON (B)(4) 2013 AS A RESULT OF AN UNACKNOWLEDGED ¿LOSS OF PRIME¿ WARNING. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO ISSUES. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER STATED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) WAS AS HIGH AS 590MG/DL WITH KETONES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED EMESIS ONCE BUT NO OTHER SYMPTOMS WERE REPORTED. THE REPORTER SAID THAT THE PATIENT¿S HEALTH CARE PROVIDER (HCP) PROVIDED ADVICE VIA PHONE CALLS; THE PATIENT WAS SAID TO HAVE CHANGED THE INFUSION SET TWICE IN 24 HOURS AND BG REMAINS ELEVATED (410MG/DL) DESPITE DELIVERY OF ADDITIONAL INSULIN VIA INJECTIONS CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE PATIENT WHO REPORTED NO ISSUES WITH THE INFUSION SET, CARTRIDGE, OR PUMP. THE SETTINGS WERE CONFIRMED AS CORRECT, THERE WERE NO RELATED ALARMS, AND THE BASAL AND BOLUS DELIVERIES APPEARED TO BE ACCURATE. CTS CONCLUDED THAT UPON REVIEW THERE WAS NOTHING TO INDICATE THAT THE PUMP WAS NOT DELIVERING AS INTENDED AND INSTRUCTED THE PATIENT AND REPORTER TO CONTINUE TO WORK WITH THEIR HCP TO RESOLVE THE BG EXCURSION ISSUES. ALTHOUGH THERE WAS NO EVIDENCE THAT THE HYPERGLYCEMIA WAS THE RESULT OF A DEVICE FAILURE OR MISUSE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED AN ADVERSE EVENT WHILE USING THE INSULIN INFUSION PUMP. THE POSSIBILITY THAT THE PUMP CONTRIBUTED TO THE INCIDENT CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304153 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening