BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2240377 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06669
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL #: 2531779-03/24/2010/003-R. THE PUMP HASBEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. A SUPPLEMENTAL REPORT WILL BE FILED AFTER EVALUATION RESULTS COME AVAILABLE. 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 (B)(6) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED A DAMAGE FORCE SENSOR ASSEMBLY AND AN OUT OF CALIBRATION FORCE SENSOR. A REVIEW OF THE PUMP HISTORY SHOWED NO EVIDENCE OF LOSS OF CARTRIDGE DETECTION; DURING TESTING, THE PUMP DISPENSED 60 UNITS OF FLUID PRIOR TO DETECTING THE FILLED CARTRIDGE.

    Additional Manufacturer Narrative · 1

    UNRELATED TO THE COMPLAINT, THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT SHE HAD BEEN HAVING ELEVATED BLOOD GLUCOSE LEVELS OF 500-600 MG/DL IN THE PAST THREE WEEKS DUE TO THE PUMP LOSING PRIME. SHE REPORTS SHE WOULD DISCONNECT AND DO A CARTRIDGE CHANGE AT THAT TIME AND NOTED THAT THE PUMP WOULD DISPENSE INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP. SHE WAS NOT CONNECTED TO THE PUMP DURING THAT TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR