BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2251991 · Received September 16, 2011

    Report

    Report Number
    2531779-2011-06859
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 11/17/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE REPORTED COMPLAINT WAS THE PUMP NOT SAVING CARBOHYDRATE INFORMATION PUT INTO THE PUMP DURING BOLUS PROGRAMMING. THE DOWNLOAD HISTORY SHOWED ONLY EZBG AND NORMAL BOLUSES. CARBOHYDRATE ENTRY IS NOT AN OPTION DURING AN EZBG BOLUS THEREFORE THE INFORMATION WOULD NOT SHOW IN THE PUMP HISTORY. NO HISTORY RECORDING ISSUES WERE FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    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. 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.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CONTACTED ANIMAS ALLEGING A MEMORY ISSUE WITH THE PUMP. THE REPORTER CLAIMED THE PUMP WAS NOT SAVING CARBOHYDRATE INFORMATION ENTERED INTO THE PUMP WHEN PROGRAMMING BOLUSES. THERE WAS NO REPORTED PATIENT IMPACT AS RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, CUSTOMER SUPPORT NOTED THAT BOLUSES ON DOWNLOAD HISTORY FROM (B)(6) 2011 SHOWED THAT EZBG MENU FEATURE WAS USED ON (B)(6) 2011, (B)(6), 2011 AND (B)(6) 2011. DURING REVIEW OF PUMP HISTORY, CUSTOMER SUPPORT NOTED THAT THE INFORMATION LISTED IN THE DOWNLOAD HISTORY CORRELATED WITH THE INFORMATION NOTED IN THE PUMP HISTORY. HOWEVER, THE REPORTER CLAIMED THE PATIENT USES EZCARB MENU 95% OF THE TIME AND INFORMATION WAS MISSING FROM THE DOWNLOAD HISTORY REPORT AND PUMP'S HISTORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED COMPLAINT WAS UNRESOLVED AT THE TIME OF 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 18 YR