BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2242016 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06701
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: REBOOTING WAS OBSERVED IN THE BLACK BOX HISTORY. NO DAMAGE WAS OBSERVED TO THE BATTERY COMPARTMENT OR CAP. THE BATTERY CAP SECURED APPROPRIATELY TO THE PUMP AND THE PUMP POWERED UP NORMALLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES OR ALARMS OCCURING. THE BATTERY CAP WAS TESTED AND NO CONTACT DEFECTS WERE FOUND. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND ON THE PCB.

    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.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THERE IS AN INTERMITTENT POWER ISSUE. REPORTEDLY, THE ANIMAS PUMP STARTED TO REBOOT SEVERAL TIME ON (B)(6) 2011. THE PATIENT STATED THAT THE ANIMAS PUMP FELL DURING PATIENT'S CHEERLEADING EVENT. THERE WAS NO PRODUCT MISUSE. THE BATTERY CAP AND COMPARTMENT WAS NOT DAMAGED. THE BATTERY COMPARTMENT WAS CORROSION FREE. THE BATTERY WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED WITH TRAINING. THE PRODUCT WAS SENT BACK FOR INVESTIGATION. THE PATIENT WAS ADVISED TO GO ON THE BACKUP PLAN. THERE WAS NO REPORT OF ANY PATIENT IMPACT ASSOCIATED WITH THE COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR