BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2943893 · Received February 5, 2013

    Report

    Report Number
    2531779-2013-01480
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 [DATE OF SUBMISSION 05/14/2013]-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 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. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING ELEVATED BLOOD GLUCOSE (BG) OF 244 MG/DL WITHOUT REPORTED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER BEGINNING USE OF THE NEW INSULIN PUMP. THE PATIENT REPORTED PRIOR TO CONNECTING TO THE NEW PUMP AND STILL CONNECTED TO HIS OLDER PUMP THE DAY OF THE REPORT, HIS BG WAS 125 MG/DL AND THEN 107 MG/DL BEFORE LUNCH. AFTER SWITCHING FROM THE OLD PUMP TO THE NEW PUMP, HIS BG MEASURED 244 MG/DL THREE HOURS AFTER EATING LUNCH. TROUBLESHOOTING BY ANIMAS CUSTOMER TECHNICAL SUPPORT WAS DECLINED BY THE PATIENT; THE PATIENT CONFIRMED ALL SETTINGS AND HISTORY WERE REVIEWED THAT MORNING AND ALL WERE CONFIRMED TO BE AS DESIRED. THE PATIENT STATED HE HAS NO CONFIDENCE IN THE NEW PUMP AND REQUESTED A REPLACEMENT PUMP. NO ALLEGATION OF PUMP MALFUNCTION WAS MADE. THE REPORTED BG ELEVATION DOES NOT MEET ANIMAS' CRITERIA OF A REPORTABLE ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED A DELIVERY MALFUNCTION WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49317 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR