BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3002285 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02672
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    FOLLOW-UP #1 05/17/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX SHOWED THAT REBOOTING HAD OCCURRED. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AND CORROSION WAS OBSERVED IN THE BATTERY COMPARTMENT. THE BATTERY CAP WAS FOUND TO BE INTACT AND WAS FOUND TO BE WITHIN SPECIFICATIONS. WHEN THE BATTERY CAP WAS ATTACHED TO THE PUMP, THE PUMP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION. A TEST CAP WAS INSERTED DURING TESTING AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT REBOOTING OCCURRING. THE PUMP WAS OPENED AND CORROSION WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, DURING TESTING, THE CONTRAST BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONDING BUT ALL OTHER BUTTONS RESPONDED APPROPRIATELY; THE CONTRAST BUTTON HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE KEYPAD WAS FOUND TO BE INTACT. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL OF THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP KEEPS REBOOTING EVERY TIME SHE BUMPS THE PUMP OR THE PUMP MOVES TOO MUCH. THE REPORTER STATED THAT LAST NIGHT WAS THE LAST TIME THE PUMP REBOOTED. THE REPORTER STATED PUMP WILL CHIRP WHEN IT REBOOTS AND THE PATIENT IS ABLE TO HEAR IT RIGHT AWAY AND THEN DISCONNECT AND REWIND, LOAD AND PRIME PUMP AGAIN. THE REPORTER STATED THAT THE BATTERY CAP WAS REPLACED THREE MONTHS AGO AND THERE IS NO DAMAGE TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE REPORTER STATED THAT THE YELLOW O-RING IS VISIBLE BECAUSE IF PT PUTS THAT BATTERY CAP ON TOO TIGHT IT MAKES THE ISSUE WORSE, SO THE PATIENT HAS TO PLAY WITH THE BATTERY CAP TO KEEP THE PUMP POWERED. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS BEING MADE DUE TO THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105924 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR