BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2111517 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03870
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    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: THERE WAS NO CORROSION OR DAMAGE NOTED TO THE BATTERY COMPARTMENT. THE PUMP WAS EXERCISED FOR SEVEN HOURS WITHOUT ANY OVERHEATING OR ALARMS. THE PUMP CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE POWER CIRCUIT CONNECTIONS WERE TESTED AND NO DEFECTS WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE PUMP WAS OPERATING ACCORDING TO SPECIFICATIONS AT THE TIME OF RELEASE.

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED NOTICING THAT THE PUMP AND BATTERY WERE HOT DURING A ROUTINE BATTERY CHANGE ON (B)(6) 2011 AFTER RECEIVING A "REPLACE BATTERY" ALARM. HE STATED THAT HE AGAIN RECEIVED A "REPLACE BATTERY" ALARM ON (B)(6) 2011. THE PATIENT CONFIRMED THAT HE IS USING A LITHIUM BATTERY, AND THAT THE BATTERY TYPE ON THE PUMP MATCHES THE BATTERY IN USE. HE STATED THAT THE BATTERY CAP WAS SECURE, AND THE PUMP DID NOT LOSE POWER. THERE WERE NO REPORTED INJURIES RELATED TO THE HOT PUMP/BATTERY. THE PATIENT STATED THAT HE DID NOT EXPERIENCE ANY BLOOD GLUCOSE (BG) EXCURSIONS.

    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 46 YR