BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2991110 · Received March 6, 2013

    Report

    Report Number
    2531779-2013-02413
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 15, 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. 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 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE UP BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND THE OTHER BUTTONS RESPONDED APPROPRIATELY. THERE WAS NO VISIBLE DAMAGE TO THE KEYPAD BUT THE SYMBOLS WERE WORN. EVALUATION REVEALED CONTAMINATION UNDER CONTRAST, UP, AND DOWN KEY CONTACTS. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE AUDIO BOLUS BUTTON COVER HAS A TEAR IN THE CENTER AND THE BUTTON IS RESPONSIVE. CONTAMINATION WAS FOUND ON THE AUDIO BOLUS BUTTON CONTACT. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 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.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE DOWN ARROW KEYPAD BUTTON WAS UNRESPONSIVE. 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
    95835 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR