BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3212392 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09920
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    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. DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA AND ALARM HISTORY REVEALED MULTIPLE ¿LOW CARTRIDGE¿ WARNINGS RECORDED. ON INVESTIGATION, THE PUMP RESPONDED APPROPRIATELY TO A LOW CARTRIDGE AND GAVE THE EXPECTED AUDIBLE AND VISUAL ALERT. THE KEYPAD WAS NOTED TO BE INTACT WITHOUT DAMAGE. ON TESTING, ALL THE KEYPAD BUTTONS HAD NORMAL RESPONSE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION OF THE BUTTON CONTACTS. INVESTIGATION WAS UNABLE TO DUPLICATE THE ALLEGED ISSUE OF THE PUMP NOT ALARMING WITH THE INSULIN IN THE CARTRIDGE IS LOW OR THE KEYPAD BUTTONS BEING UNRESPONSIVE. THE PUMP WAS FOUND TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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) 2013, THE REPORTER ALLEGED THAT BEGINNING A FEW MONTHS PRIOR, THE UP ARROW AND DOWN BUTTONS HAVE DELAYED RESPONSE WHEN PRESSED. THE REPORTER ALSO ALLEGED THAT THE PUMP DOES NOT ALARM WHEN THE INSULIN IN THE CARTRIDGE IS LOW. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED KEYPAD MALFUNCTION AND ALARM MALFUNCTION REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312275 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR