BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191091 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09043
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/23/2013 - 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 HISTORY SHOWS REBOOTING. MOISTURE CORROSION WAS OBSERVED IN THE BATTERY COMPARTMENT AND A LEAK TEST FOUND A CRACK IN THE PUMP CASING. NO DAMAGE WAS FOUND TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP CONTACT WIDTH AND HEIGHT WERE FOUND TO BE WITHIN SPECIFICATIONS AND THE CAP ATTACHED SECURELY TO THE PUMP. DURING TESTING, THE PUMP POWERED ON APPROPRIATELY WITH NO ALARMS OCCURRING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS FOUND ON THE PRINTED CIRCUIT BOARD.

    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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THE PUMP HAD LOST POWER WITHOUT USER INTERVENTION. REPORTEDLY, THE BATTERY HAD ¿EXPLODED¿ INSIDE THE PUMP¿S BATTERY COMPARTMENT. BATTERY ACID WAS VISIBLE INSIDE THE BATTERY COMPARTMENT WHEN THE BATTERY CAP WAS REMOVED. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS REPORTED TO BE IN THE 400 MG/DL RANGE WITH NO SYMPTOMS, WHICH DOES NOT MEET THE ANIMAS CRITERIA FOR AN ADVERSE EVENT OR SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291085 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR