BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2250221 · Received September 15, 2011

    Report

    Report Number
    2531779-2011-06847
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY CAP HUB AND SPRING ARE CORRODED; THERE WAS NO PHYSICAL DAMAGE NOTED TO THE BATTERY COMPARTMENT. THE PUMP DOES NOT POWER ON WITH THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP. A TEST BATTERY CAP WAS USED TO COMPLETE TESTING. THE PUMP POWERS ON APPROPRIATELY TO THE VERIFICATION SCREEN, WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. A REVIEW OF THE PUMP HISTORY INDICATED MULTIPLE REBOOTS HAD OCCURRED IN ASSOCIATION WITH LOW BATTERIES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES. A DAMAGED BATTERY CAP IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. 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

    IT WAS REPORTED THE PUMP WOULD NOT POWER ON. THE PATIENT REPLACED THE BATTERY SUCCESSFULLY AND THERE WAS NO DAMAGE SEEN TO THE BATTERY CAP OR COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1