BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3243651 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11774
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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

    THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/18/2013 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION SHOWED SOME COSMETIC DAMAGES AND A CRACK WAS OBSERVED ON THE PUMP CASING. INVESTIGATION WAS UNABLE TO DUPLICATE THE ¿INTERMITTENT POWER¿ COMPLAINT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OR POWER RELATED ALARMS. REVIEW OF ALARM HISTORY SHOWED POWER LOSSES IN THE PUMP HISTORY. NO EVIDENCE OF MOISTURE WAS OBSERVED IN THE BATTERY COMPARTMENT OR THE PUMP INTERIOR. BATTERY CAP WAS ABLE TO TIGHTEN PROPERLY. INSPECTION OF BATTERY CAP SHOWED THAT THE MEASUREMENTS WERE OUT OF SPECIFICATION. UNRELATED TO THIS COMPLAINT, THE DEVICE POWERED UP TO A DIM AND DISCOLORED VERIFY SCREEN. THE DISPLAY SCREEN WAS REPLACED WITH A TEST DISPLAY, AND THE TEST DISPLAY SCREEN WAS FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THEIR PUMP WAS INTERMITTENTLY POWERING OFF AND ON. THE USER STATED THAT THEY HAD RECENTLY CHANGED THE BATTERY BUT DENIED ANY DAMAGE TO THE BATTERY CAP OR COMPARTMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342928 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR