BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2918748 · Received January 16, 2013

    Report

    Report Number
    2531779-2013-00725
    Event Type
    Injury
    Date Received
    January 16, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (INADEQUATE USE OF THE PUMO).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS: NO POWER ISSUES OBSERVED IN BLACK BOX. BLACK BOX AND HISTORIES FOR ISSUE REPORTED ON (B)(6) 2012 HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. THE BATTERY CAP WAS UNAVAILABLE FOR TESTING; A TEST CAP WAS USED FOR ALL INVESTIGATION STEPS. TEST CAP ABLE TO SECURE TO PUMP PROPERLY. THE PUMP POWERS ON PROPERLY WITHOUT ALARM. DURING REWIND PUMP GIVES A CALL SERVICE 078-0008 ALARM. UNABLE TO PERFORM STEPS 17- 22 AND 31 DUE TO RECURRING ALARM. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PUMP LOST POWER WHILE PATIENT WAS SKIING BECAUSE THE BATTERY CAP CAME LOOSE. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE (BG) WENT UP TO 600MG/DL WITH NAUSEA. THE PATIENT TREATED WITH A CORRECTION BOLUS FROM THE PUMP. THE REPORTER STATED THAT THE THREADS ON THE BATTERY CAP ARE WORN AND THE CAP KEEPS SPINNING WHEN TRYING TO PLACE THE CAP ON THE PUMP. THE REPORTER STATED THAT THE PATIENT IS UNABLE TO KEEP BATTERY CAP ON THE PUMP WITH TAPE. THE REPORTER DENIED CRACKS TO THE BATTERY COMPARTMENT. CUSTOMER SUPPORT INSTRUCTED THAT THE PATIENT DISCONTINUE USE OF THE PUMP AND USE ALTERNATE FORM OF INSULIN DELIVERY. THE PUMP IS NOT BEING RETURNED AND THE BATTERY CAP WAS REPLACED. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM AN INADEQUATE USE OF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24416 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening