BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3041321 · Received April 8, 2013

    Report

    Report Number
    2531779-2013-03796
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 14, 2013
    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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED THAT THE BATTERY VOLTAGE DROPPED ON (B)(6) 2012. NO PHYSICAL DAMAGE WAS OBSERVED TO BATTERY CAP OR BATTERY COMPARTMENT. THE PUMP POWERED ON TO ¿VERIFY¿ SCREEN WITH NO ISSUES NOTED. THE PUMP WAS PRIMED AND EXERCISED WITH NO OVERHEATING OBSERVED. AN EXTERNAL POWER SUPPLY WAS USED TO CONFIRM THAT ALL CURRENT DRAWS WERE FOUND TO BE WITHIN SPECIFICATION. THE PUMP WAS OPENED AND NO MOISTURE INGRESS WAS NOTED ON THE PCB; NO INTERMITTENT ISSUES WERE FOUND TO THE POWER CIRCUIT OR POWER FLEX.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) ISSUE. THE PATIENT STATED THAT SHE AWOKE FROM A NAP AND THE PUMP FELT HOT. THE PATIENT NOTED THAT THE BATTERY FELT HOT WHEN SHE REMOVED IT. THERE WAS NO PHYSICAL DAMAGE NOTED TO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143983 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR