BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2880042 · Received December 19, 2012

    Report

    Report Number
    2531779-2012-14864
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 01/30/2013, DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY DID NOT REVEAL ANY LOAD STEP MALFUNCTIONS OR ANY LOSS OF PRIME WARNINGS. ON TESTING, THE PUMP POWERED ON NORMALLY. AN EZ-PRIME FUNCTION WAS PERFORMED SUCCESSFULLY. TEST REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THE FORCE SENSOR RESISTANCE TEST REVEALED THE FORCE SENSOR TO BE WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP WAS USING MORE INSULIN DURING THE PRIMING AND LOAD STEP THAN USUAL. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE PATIENT TO TROUBLESHOOT THE PUMP, HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR