BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4152969 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28640
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01-AUG -2019 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX SHOWED NO POWER INTERRUPTIONS. THERE WAS NO DATA IN THE PUMP HISTORIES FROM THE TIME OF THE REPORTED ISSUE DUE TO CONTINUED USE OF THE PUMP. NO DAMAGE WAS FOUND TO THE RETURNED BATTERY CAP. THE BATTERY CAP CONTACT HEIGHT AND WIDTH MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATION. THE BATTERY CAP ATTACHED SECURELY TO PUMP TO MAINTAIN AN ELECTRICAL CONNECTION. THE PUMP POWERED ON WITH AUDIBLE TONES AND VIBRATIONS INDICATING THAT THERE WAS POWER TO THE PUMP. THE PUMP WAS EXERCISED FOR 12 HOURS WITH NO POWER INTERRUPTIONS OCCURRING. THE PUMP¿S COVER WAS REMOVED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WERE OBSERVED TO THE POWER PRINTED CIRCUIT BOARD. THE COMPLAINT OF INTERMITTENT POWER WAS NOT DUPLICATED DURING INVESTIGATION. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER ALLEGED THAT THE YELLOW O-RING AT THE BATTERY CAP WAS VISIBLE AT THE TIME OF POWER INTERRUPTION. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632221 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR