BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2761202 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11319
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX INDICATED REBOOTING HAD OCCURRED. VISUAL INSPECTION REVEALED NO DAMAGE TO THE BATTERY COMPARTMENT OR BATTERY CAP. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP. THERE WERE NO BATTERY CAP CONTACT DEFECTS OBSERVED. A REWIND, LOAD, AND PRIME SEQUENCED WAS PERFORMED WITH NO POWER ISSUES OCCURRING. THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION. 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) 2012, THE PATIENT CONTACTED ANIMAS, ALLEGING AN INTERMITTENT POWER ISSUE. THE PATIENT REPORTED THAT EVENING THE PUMP REBOOTED ITSELF MULTIPLE TIMES. THE PATIENT STATED HE WOULD RESET THE PUMP AND IT WOULD RE-BOOT. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY VISIBLE DAMAGE TO THE PUMP'S CASING OR BATTERY CAP. THE PATIENT DENIED ANY EVIDENCE OF MOISTURE INGRESS AND CONFIRMED THE BATTERY CAP WAS SECURED TO THE PUMP. 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
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR