BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3842336 · Received June 1, 2014

    Report

    Report Number
    2531779-2014-15431
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/11/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/03/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THERE WAS MOISTURE BEHIND THE DISPLAY LENS. NO BATTERY CAP WAS RETURNED WITH THE PUMP. A TEST BATTERY CAP WAS USED TO COMPLETE ALL TESTING. THE BATTERY CAP WAS ABLE TO BE FULLY SECURED TO THE PUMP. THE BATTERY COMPARTMENT WAS INTACT; NO DAMAGE WAS OBSERVED. THE PUMP CASE WAS FOUND TO BE CRACKED IN THE RIGHT HAND CORNER OF THE DISPLAY AREA. DURING TESTING, THE PUMP POWERED ON WITH AUDIO TONES ONLY; THE DISPLAY WAS BLANK AND PUMP VIBRATIONS WERE NOT FUNCTIONING. A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND AT THE CRACK IN THE PUMP CASE. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE THE PUMP. THE BATTERY LIFE ISSUE WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE BLANK DISPLAY AND INTERNAL MOISTURE DAMAGE. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. IT WAS REPORTED THAT THE PUMP¿S BATTERY LIFE WAS SHORTER THAN EXPECTED. A REVIEW OF THE ALARM HISTORY CONFIRMED MULTIPLE LOW BATTERY AND REPLACE BATTERY ALARMS HAD OCCURRED. 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
    320736 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR