BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4093235 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26388
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/04/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/14/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND ALARM HISTORY SHOWED SEVERAL CALL SERVICE ALARMS. THE BATTERY AND CARTRIDGE CAPS WERE NOT RETURNED WITH THE PUMP; TEST BATTERY AND CARTRIDGE CAPS WERE USED TO COMPLETE THE INVESTIGATION WITHOUT INCIDENT. NO CALL SERVICE ALARMS OR ANY OTHER ALARMS OCCURRED DURING THE INVESTIGATION; THE PRODUCT PERFORMED WITHIN SPECIFICATION. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE INITIAL COMPLAINT. 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.

    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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A CALL SERVICE ALARM ISSUE. THE REPORTER STATED THAT A CALL SERVICE ALARM HAD OCCURRED 3 TIMES IN 30 DAYS. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571042 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR