BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2761288 · Received September 26, 2012

    Report

    Report Number
    2531779-2012-11323
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 29, 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 FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-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 SHOWS FOUR BOLUSES RECORDED ON THE REPORTED COMPLAINT DATE, (B)(4) 2012. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD BUTTONS WERE TESTED AND WERE FOUND TO BE RESPONDING APPROPRIATELY; THERE WAS NO HYPERSENSITIVITY OBSERVED WITH THE KEYPAD BUTTONS. THE COMPLAINT COULD NOT BE DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HER SON (THE PATIENT) ALLEGING THAT THE PUMP'S BOLUS HISTORY WAS INACCURATE. THE REPORTER DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE REPORTER CLAIMED THAT AFTER DELIVERING A BOLUS, THE PUMP'S HISTORY WOULD NOT DISPLAY THE BOLUS. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PUMP WAS REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PUMP HAD AN INACCURATE BOLUS HISTORY ISSUE. HOWEVER, THERE IS NO EVIDENCE THAT THE PUMP CONTRIBUTED TO A SERIOUS INJURY. THE REPORTER DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS, AND/OR TREATMENT SUGGESTIVE OF A SERIOUS INJURY.

    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 10 YR