BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6071685 · Received November 1, 2016

    Report

    Report Number
    2531779-2016-30328
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    October 6, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 01/06/2017 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/15/2016 WITH THE FOLLOWING FINDINGS: CALL SERVICE 06 ALARMS OBSERVED IN BLACK BOX BUT NOT IN THE ALARM HISTORY. THE PUMP POWERS ON TO A CALL SERVICE 06 ALARM. CALL SERVICE 06 ALARM IS DEFINED AS A MEMORY ERROR, THEREFORE PUMP IS UNABLE TO RECORD THE ALARM IN THE ALARM HISTORY. 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. 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) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT THE PATIENT RECEIVED 3 CS 006-0001 ALARMS TODAY THAT ARE NOT RECORDED IN THE PUMP HISTORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722378 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR