BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2033415 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01823
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 20, 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

    AFTER THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PT CLAIMED THAT THE ANIMAS INSULIN PUMP IS PROMPTING HER TO VERIFY THE DATE AND TIME ON TWO OCCASIONS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE INDICATED THAT PT CHANGED HER BATTERY CAP ON (B)(6) 2011 AND USES A COIN TO TIGHTEN CAP. PT REPORTS BATTERY CAP IS TIGHT AND O-RING IS NOT VISIBLE. BATTERY CAP SPRING IS INTACT AND THREADING IS GOOD. THERE WERE NO CRACKS ON PUMP. THREADING ON PUMP BATTERY COMPARTMENT LOOKED GOOD AND WAS NOT WORN. IT WAS CONCLUDED THAT THE ISSUE COULD BE DUE TO A SHORT BATTERY LIFE ISSUE POSSIBLE DUE TO SYSTEM FAILURE. THERE IS NO EVIDENCE THAT THE ALLEGED PRODUCT CONTRIBUTED OR CAUSED A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1