BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3112337 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06393
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THAT THE DISPLAY SCREEN HAD BEEN BLANK FOR THE PAST TWO WEEKS. BATTERY REPLACEMENT DID NOT RESOLVE THE DISPLAY ISSUE. ADDITIONALLY, THE REPORTER STATED THAT THE PUMP WOULD NOT POWER ON AND THIS HAPPENED ABOUT A MONTH AGO DIRECTLY FOLLOWING AN OCCLUSION ALARM AND LOSS OF PRIME. CHANGING THE BATTERIES DID NOT RESOLVE THIS ISSUE. THE REPORTER STATED THAT THE BATTERY CAP IS SECURELY ATTACHED TO THE PUMP WITHOUT THE YELLOW O-RING VISIBLE. THE REPORTER CONFIRMED THAT THERE WAS NO DAMAGE TO THE PUMP'S CASING AND NO MOISTURE IN THE PUMP. THE REPORTER ALSO STATED THE DOWN ARROW BUTTON HAD BE PRESSED VERY HARD IN ORDER TO EVOKE A RESPONSE. THE KEYPAD WAS REPORTEDLY INTACT. THE REPORTER STATED THE PATIENT EXPERIENCED BLOOD GLUCOSE OF 300 MG/DL WITH FREQUENT URINATION. THIS REPORTED BG DOES NOT MEET ANIMAS' CRITERIA OF A REPORTABLE ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED BLANK DISPLAY, KEYPAD MALFUNCTION AND LOSS OF POWER REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212051 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR