BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3033801 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03528
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/26/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/28/2013 WITH THE FOLLOWING FINDINGS: DISPLAY IS INTERMITTENTLY FUNCTIONAL / ILLUMINATED. REMOVED PUMP CASE, MOISTURE CONTAMINATION FOUND ON DISPLAY FLEX CABLE AND DISPLAY FLEX CONNECTOR. THE VIBRATION MOTOR NOT RESPONDING DUE TO INTERNAL MOISTURE DAMAGE. AUDIO BOLUS" BUTTON COVER IS TORN IN THE CENTER. REMOVED ¿AUDIO BOLUS¿ BUTTON COVER, CONTAMINATION FOUND ON BUTTON CONTACT.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 AND STATED THE DISPLAY SCREEN WAS BLANK. THE PATIENT REPORTEDLY CHANGED THE BATTERY AND THE PUMP POWERED ON WITH AUDIBLE TONES AND THE SCREEN REMAINED BLANK. 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
    136719 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR