BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3173587 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08355
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION; HOWEVER, PRODUCT INVESTIGATION HAS NOT BEEN COMPLETED. ONCE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT¿S MOM/REPORTER CONTACTED ANIMAS ON BEHALF OF THE PATIENT TO REPORT OF ELEVATED BLOOD GLUCOSE FROM 274 TO 305 MG/DL DUE TO NOT COUNTING THE ACTUAL CARBOHYDRATE INTAKE FOR LUNCH AND AFTERNOON SNACKS. THERE WAS NO REPORT OF ANY SYMPTOMS OR REQUIRED HCP MEDICAL INTERVENTION TO SUGGEST A SERIOUS INJURY. HOWEVER, THE PATIENT REPORTEDLY HAS BEEN URINATING MORE THAN USUAL. THE SUBJECT PUMP WAS NOT AVAILABLE FOR REVIEW AT THE TIME OF THE CALL. ANIMAS HAS MADE 3 ATTEMPTS TO CONTACT THE REPORTER BACK FOR MORE INFORMATION BUT WAS NOT SUCCESSFUL. A LETTER WAS SENT TO THE PATIENT, REQUESTING A CALL BACK. THIS COMPLAINT IS BEING REPORTED DUE TO AN UNRESOLVED INSULIN PUMP DELIVER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273739 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR