BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3100479 · Received May 8, 2013

    Report

    Report Number
    2531779-2013-06044
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 13, 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 07/16/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/17/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT REBOOTING OBSERVED IN THE BLACK BOX. A LOW BATTERY WARNING WAS CONFIRMED. THE VOLTAGE IN THE BLACK BOX IS LOW. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT. BATTERY CAP CONTACT HEIGHT AND WIDTH WERE FOUND TO BE IN SPECIFICATIONS. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED WITH NO DEFECTS FOUND. A REPLACE BATTERY ALARM WAS REPRODUCED DURING TESTING; THE PUMP GAVE AN AUDIBLE AND VISUAL ALERT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER ISSUES OCCURRING. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT.

    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 (NO POWER) ISSUE. THE REPORTER STATED THAT AFTER CHANGING THE BATTERY, THE PUMP WOULD NOT POWER ON. 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
    201238 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR