BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5855509 · Received August 8, 2016

    Report

    Report Number
    2531779-2016-19515
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Report Date
    July 18, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 DATE OF SUBMISSION 10/06/2016-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/12/2016 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE CALL SERVICE 6 AND 020 ALARM OBSERVED IN BLACK BOX. AT POWER ON PUMP DISPLAYS ¿RE-INITIALIZING. PLEASE WAIT¿ SHORTLY AFTER POWERING ON PUMP GIVES A CALL SERVICE 020 ALARM. TEST CODE DOWNLOADER TOOL APPLICATION V 1.0.0 USED TO UPLOAD TEST CODE V 1.0.4 TO MASTER/SLAVE/PERIPH PROCESSORS AS PER (6000975), UPLOAD WAS SUCCESSFUL, PUMP POWERS UP AND DISPLAY JUST ¿MSP¿ INSTEAD OF ¿MSP2¿. THE PUMP NORMALLY DISPLAYS ¿MSP2¿ INDICATING MASTER (M) HAS BOOTED PROPERLY AND THEN THE SLAVE (S) HAS BOOTED PROPERLY AND COMMUNICATING AND THEN THE PERIPHERALS (P) HAS DONE LIKEWISE. THE (2) IS THE EEPROM COMMUNICATING PROPERLY HENCE THE DIAGNOSIS THAT THE FAILURE IS IN THIS AREA SINCE IT IS MISSING FROM THE DISPLAY. EEPROM FAILURE IS CONCLUDED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP ALARMED FOR CALL SERVICE 020. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506312 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR