BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5765165 · Received July 1, 2016

    Report

    Report Number
    2531779-2016-14312
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Report Date
    June 16, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/08/2016. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/14/2016 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE PUMP SHOWED THAT THE BATTERY COMPARTMENT WAS CRACKED. DURING TESTING, THE PUMP EMITTED A CALL SERVICE 069 ALARM. THE PUMP¿S COVER WAS REMOVED, NO INTERMITTENT CONDITION WAS FOUND TO THE PRINTED CIRCUIT BOARD (PCB). A TEST CODE DOWNLOADER TOOL APPLICATION V 1.0.0 WAS USED TO UPLOAD TEST CODE V 1.0.4 TO MASTER/SLAVE/PERIPH PROCESSORS AS PER (6000975). THE UPLOAD WAS SUCCESSFUL, THE PUMP POWERS UP AND DISPLAY JUST ¿MSP¿ INSTEAD OF ¿MSP2¿. THE PUMP NORMALLY DISPLAYS ¿MSP2¿ AS AN INDICATION THAT THE MASTER (M) HAS BOOTED PROPERLY AND THEN THE SLAVE (S) HAS BOOTED PROPERLY 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. AN EEPROM FAILURE WAS CONCLUDED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM ISSUE. IT WAS REPORTED THAT A 069-0000 CALL SERVICE ALARM WAS EMITTED MORE THAN EXPECTED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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
    421248 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR