BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2874498 · Received December 14, 2012

    Report

    Report Number
    2531779-2012-14599
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 14, 2012
    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

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. DURING THE PUMP LOAD CARTRIDGE STEP, THE PUMP FAILED TO DETECT THE FILLED CARTRIDGE. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND IN THE FORCE SENSOR ASSEMBLY. UNRELATED TO THE COMPLAINT, THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENT AND CONTAMINATION WAS FOUND UNDER THE BUTTON CONTACTS. ALSO UNRELATED, THE BOLUS BUTTON WAS FOUND TO BE TORN AND WAS HARD TO PRESS. ALSO UNRELATED, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. ALSO UNRELATED, THE DISPLAY SCREEN WAS FOUND TO BE FADED. PLEASE DISREGARD REPORT NUMBER 2531779-2012-14415 WHICH IS A DUPLICATE OF THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(4) 2012, THE PATIENT CONTACTED ANIMAS AND REPORTED A LOAD STEP MALFUNCTION. THE PUMP REPORTEDLY DISPENSED INSULIN DURING THE LOAD STEP EMPTYING THE CARTRIDGE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    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 46 YR