BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2070816 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02656
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP AND METER HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP AND THE METER BOTH POWERED UP NORMALLY, AND WERE SUCCESSFULLY PAIRED DURING INVESTIGATION. BOTH PRODUCTS PASSED RADIO-FREQUENCY (RF) TESTING. A REVIEW OF THE PUMP HISTORY INDICATED THAT THERE WAS ONE CANCELLED BOLUS; THERE WAS NO ACTIVITY OUTSIDE OF NORMAL USE NOTED IN THE PUMP HISTORY. DURING INVESTIGATION, BOLUSES WERE PROGRAMMED AND DELIVERED USING THE METER REMOTE WITH NO ERRORS OCCURRING. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PUMP INDICATED THAT THE PUMP WAS PERFORMING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE COMPLAINT COULD NOT BE VERIFIED OR DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT STATED HE PROGRAMMED THE BOLUS AMOUNT OF INSULIN FROM HIS METER REMOTE AND WATCHED HIS INSULIN DELIVER THE ENTIRE PROGRAMMED AMOUNT OF INSULIN BEFORE HE PUTS HIS INSULIN PUMP BACK IN HIS POUCH. HE CLAIMED THAT 45 MINUTES AFTER LATER, THE PUMP WOULD VIBRATE AND SHOW THAT PART OF HIS PROGRAMMED BOLUS INSULIN WAS CANCELLED. THE PATIENT INDICATED THAT THIS ISSUE HAS OCCURRED TWICE: ONCE ON (B)(6) 2011 AND ANOTHER TIME ON (B)(6) 2011. THE ANIMAS' REPRESENTATIVE NOTED THAT THE CANCELLED BOLUSES WERE NOTED IN THE PUMP'S HISTORY. THE PATIENT ALSO INDICATED THAT BOTH HIS METER REMOVED AND INSULIN PUMP ARE PROPERLY PAIRED FOR COMMUNICATION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1