BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091752 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03479
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EXERCISED FOR 24 HRS, NO OVERHEATING OR POWER ISSUES WERE DUPLICATED. COMPLAINT REGARDING PUMP AND BATTERY OVERHEATING COULD NOT BE DUPLICATED DURING INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP WAS PERFORMED AND THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. SOFTWARE VERSION: E3A, DATE OF MANUFACTURE: 9/2009.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT THE PUMP FELT HOT AGAINST HER SKIN APPROXIMATELY 2 HOURS AFTER A BATTERY CHANGE. SHE STATED THAT SHE HAD REPLACED THE BATTERY WITH A LITHIUM ADVANCED BATTERY AND CONFIRMED THE BATTERY TYPE TO MATCH THE PUMP. THE PATIENT STATED SHE WAS NOT BURNED, AND THERE WAS NO REPORTED TREATMENT. SHE STATED THAT THERE WERE NO SIGNS OF CORROSION IN THE BATTERY COMPARTMENT OR ON THE BATTERY. THE PATIENT REPORTED THAT THE BATTERY CAP WAS SECURE AT THE TIME OF THE INCIDENT, AND THAT THERE WAS NO PHYSICAL DAMAGE TO THE BATTERY CAP OR THE BATTERY COMPARTMENT. SHE DENIED EXPOSING THE PUMP TO MOISTURE. THE PATIENT STATED THAT THE BATTERY CAP IS THE ORIGINAL CAP AND HAS NEVER BEEN CHANGED. THE PATIENT WAS ADVISED OF ANIMAS' RECOMMENDATIONS TO CHANGE THE BATTERY CAP EVERY 6 MONTHS IN GENERAL, AND EVERY 3 MONTHS IF THE PUMP IS EXPOSED FREQUENTLY TO WATER OR DUSTY ENVIRONMENTS. THE PATIENT REPORTED THAT THE FRONT OF THE LCD SCREEN HAS LIFTED AT THE TOP RIGHT AND BOTTOM RIGHT CORNERS. SHE NOTED THAT THE OK KEYPAD BUTTON IS WORN, BUT DENIED TEARS OR HOLES IN THE KEYPAD. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION THAT THE PUMP BECAME HOT TO THE TOUCH.

    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 31 YR