BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222230 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10364
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/10/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/25/2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED DATES FROM 04/24/2013- 05/03/2013, BEFORE THE COMPLAINT DATE. THERE WERE REBOOTS VISIBLE IN THE PUMP¿S HISTORY. A VISUAL INSPECTION OF THE PUMP SHOWED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP AND A TEST CAP WAS USED WITH NO POWER LOSS. THE PUMP COVER WAS REMOVED AND NO DAMAGE OR MOISTURE WAS FOUND TO THE INTERNAL COMPONENTS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS BLANK. THE SCREEN WAS FOUND TO BE CRACKED. A TEST SCREEN WAS INSTALLED AND DISPLAYED NORMALLY. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THE REPORTER STATED THE PUMP ¿LOST POWER¿ TODAY. THE REPORTER STATED HE TRIED TO CHANGE THE BATTERY IN THE MORNING AND THE ISSUE PERSISTED, THE BATTERY CAP WAS SECURE. 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
    324253 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR