BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3172455 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08277
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 19, 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

    FOLLOW-UP #1 DATE OF SUBMISSION 08/14/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT POWER ON RESETS WERE OBSERVED IN THE BLACK BOX. THERE WAS NO DAMAGE FOUND TO THE RETURNED BATTERY CAP OR THE BATTERY COMPARTMENT. THE RETURNED BATTERY CAP IS SECURE ON THE PUMP AND THE YELLOW O RING IS NOT VISIBLE. THERE WAS NO POWER INTERRUPTIONS DUPLICATED WHEN THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE RETURNED BATTERY CAP. NO BATTERY CAP CONNECTION DEFECTS WERE OBSERVED. THE RETURNED BATTERY CAP HEIGHT AND WIDTH WAS FOUND TO BE IN REQUIRED SPECIFICATIONS. TO FURTHER INVESTIGATE THE PUMP COVER WAS REMOVED; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT OR BATTERY FLEX WAS FOUND. THE POWER COMPLAINT WAS VERIFIED IN THE HISTORY BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED.

    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. 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 (INTERMITTENT POWER) ISSUE. THE REPORTER STATED THE PUMP REBOOTED TO THE VERIFY SCREEN WITHOUT USER INTERVENTION. 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
    274043 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR