BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2424064 · Received January 20, 2012

    Report

    Report Number
    2531779-2012-00504
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Report Date
    December 25, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    (B)(4). DEVICE EVALUATION: THE PUMP, CARTRIDGE, AND INFUSION SET HAVE BEEN RETURNED FOR INVESTIGATION. THE CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012, AND THE PUMP WAS EVALUATED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WERE NO PUMP DEFECTS FOUND ON INVESTIGATION. FOUR CARTRIDGES FROM LOT # B201665 WERE RETURNED AND INVESTIGATED. THE CARTRIDGES PASS VISUAL INSPECTION; NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGES. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGES. THERE WERE NO DEFECTS FOUND WITH EITHER THE PUMP OR THE CARTRIDGES ON INVESTIGATION; THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED. ANIMAS DOES NOT MANUFACTURE THE INFUSION SET BUT WILL FORWARD THE COMPLAINT TO THE RELEVANT MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT SHE IS CONTINUALLY HAVING ISSUES WITH AIR BUBBLE WITH THE ANIMAS INSULIN PUMP SYSTEM. THERE WAS NO PRODUCT MISUSE. THERE WAS NO VISIBLE DAMAGE ON THE INFUSION SET, CARTRIDGE, OR INSULIN PUMP. THE INFUSION SET IS SECURE TO CARTRIDGE AT THE LUER LOCK CONNECTION. THERE WAS NO AIR BUBBLE IN THE ANIMAS INSULIN PUMP SYSTEM DURING TROUBLESHOOTING. THE ISSUE WAS NOT RESOLVED DURING TRAINING. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED AIR BUBBLE ISSUE. THE ANIMAS INSULIN PUMP SYSTEM WAS REQUEST BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP B201695

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR