BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2770261 · Received October 3, 2012

    Report

    Report Number
    2531779-2012-11697
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED SIX "PARTIAL DELIVERY, USER ABORTED" WARNINGS ON (B)(6) 2012. THE KEYPAD WAS TESTED AN ALL BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY. THERE WERE NO HYPERSENSITIVE KEYPAD BUTTONS OBSERVED. A 10 UNIT AUDIO BOLUS AND A 10 UNIT NORMAL BOLUS WERE SUCCESSFULLY PERFORMED AND ACCURATELY RECORDED IN THE PUMP HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO WARNINGS OR ALARMS OCCURRING. THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION.

    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)(4) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP CANCELED BOLUS DOSES WITHOUT USER INTERVENTION, WITHOUT THE USER PRESSING ANY KEYS OR BUTTONS ON THE PUMP. THE PATIENT NOTED THERE WERE NO ISSUES OR DAMAGE WITH THE KEYPAD. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    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 65 YR