BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3172823 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08316
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/15/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED NO EVIDENCE OF POWER ON RESETS. THERE WAS NO DAMAGE TO THE RETURNED BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP SECURED TIGHTLY TO THE PUMP WITH NO YELLOW O-RING VISIBLE. THE BATTERY CAP MEASUREMENTS WERE FOUND TO MEET SPECIFICATION. NO BATTERY CAP CONNECTION DEFECTS WERE OBSERVED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE BATTERY CAP; NO POWER ISSUES WERE NOTED. THE PUMP COVER WAS REMOVED; NO INTERMITTENT CONNECTIONS OR LOOSE COMPONENTS WERE NOTED. NO EVIDENCE OF MOISTURE CONTAMINATION WAS NOTED INSIDE THE PUMP. THE REPORTED POWER ISSUE WAS FOUND IN PUMP HISTORY BUT WAS NOT DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DISCOLORED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THAT THE PUMP WAS REBOOTING WITHOUT USER INTERVENTION. THE REPORTER ATTEMPTED TO MULTIPLE NEW BATTERY BUT THE ISSUE CONTINUED. 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
    273391 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR