BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2153660 · Received July 7, 2011

    Report

    Report Number
    2531779-2011-04761
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 13, 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

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP'S ALARM HISTORY INDICATED MULTIPLE "REPLACE BATTERY" ALARMS HAD OCCURRED. THE PUMP POWERS ON NORMALLY WITH NO ALARMS. THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP OR COMPARTMENT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OR ALARMS OCCURRING. THE PUMP ELECTRICAL DRAWS WERE TESTED AND FOUND TO BE OUT OF SPECIFICATION. A CASE SEAL LEAK WAS FOUND DURING LEAK TESTING, AND THERE WAS EVIDENCE OF INTERNAL MOISTURE DAMAGE FOUND. 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.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED THIS COMPLAINT. THE PATIENT REPORTED THAT THE PUMP REQUIRES FREQUENT BATTERY CHANGES. HE STATED THAT THE BATTERY ONLY LASTS A COUPLE OF DAYS. HE REPORTED THAT THE BATTERY AND PUMP WERE HOT. HE TOOK BATTERY OUT AND LET THE PUMP COOL. HE INSERTED A NEW BATTERY AND THE PUMP WOULD NOT TURN ON. THE PATIENT ALSO STATED THAT OVERNIGHT THE PUMP BEEPED AND HE SAW THE VERIFY SCREEN REQUIRING FULL REWIND. THE PATIENT REPORTED WATER DAMAGE IN TOP LEFT OF THE SCREEN.

    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