BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4130947 · Received September 30, 2014

    Report

    Report Number
    2531779-2014-27947
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/13/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/24/2015 WITH THE FOLLOWING FINDINGS: BLACK BOX SHOWS DATES FROM 8/16/2015 -8/25/2015. BLACK BOX DATA FROM DATE OF COMPLAINT HAS BEEN OVERWRITTEN HOWEVER CURRENT BB SHOWS ONE EAW 162 LOSS OF PRIME WARNING WITH A NON ZERO LOW FORCE ON 8/23/2015. THE PUMP POWERS WITH RETURNED BATTERY CAP. EXERCISED PUMP FOR 24 HOURS WITH A 1 UNIT PER HOUR BASAL PROGRAM. NO LOSS OF PRIME OR PRIME RELATED WARNINGS DUPLICATED. FORCE CALIBRATION CHECK PASSES WITH A READING OF 170. REMOVED PUMP CASE. FORCE SENSOR PINS SEATED AND SOLDER CONNECTIONS INTACT. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. 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
    607986 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR