BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2821441 · Received November 6, 2012

    Report

    Report Number
    2531779-2012-13219
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS (ANM) ON BEHALF OF HER DAUGHTER (THE PATIENT) AND REPORTED ERRATIC BLOOD GLUCOSE (BG) LEVELS. THE REPORTER ALLEGED THAT THE PUMP POSSIBLY HAD AN INACCURATE DELIVERY ISSUE. THE REPORTER INITIALLY INFORMED AN ANM REPRESENTATIVE FROM THE INTERNAL SALES DEPARTMENT (ISD) ABOUT THE ERRATIC BGS. THE PATIENT WAS REPORTEDLY GETTING A NEW PUMP FROM ISD. THE REPORTER WAS CALLED BACK BY AN ANM REPRESENTATIVE TO OBTAIN FOLLOW-UP INFORMATION. HOWEVER, THE REPORTER REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION. NO SYMPTOMS, BG VALUES, OR TREATMENT WERE REPORTED DURING THE FOLLOW-UP CONTACT WITH THE REPORTER. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PUMP HAD AN INACCURATE DELIVERY 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