BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3052150 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04042
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/25/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED DATES FROM (B)(6) 2013-(B)(6) 2013 WITH ONE LOW BATTERY WARNING AND ONE REPLACE BATTERY ALARM. ON (B)(6) 2013 THERE WAS AN UNCONFIRMED REPLACE BATTERY ALARM FOLLOWED BY A REBOOT. THE REBOOT WENT UNACKNOWLEDGED FROM 08:13-16:41. DURING EVALUATION OF THE PUMP, NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO BE FULLY TIGHTENED AND THE PUMP WAS EXERCISED WITH NO POWER LOSS. A TEAR WAS NOTED ON THE AUDIO BOLUS BUTTON COVER; THE BUTTON WAS RESPONSIVE AND NO CONTAMINATION WAS FOUND ON THE BUTTON CONTACT. NO EVIDENCE OF INTERNAL MOISTURE CORROSION WAS FOUND IN THE PUMP. THE PUMP COVER WAS REMOVED AND NO DAMAGE WAS FOUND TO THE INTERNAL COMPONENTS.

    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 CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT HE AWAKEN BY HIS PUMP MAKING NOISES AND THE DISPLAY WAS FLASHING. THE PATIENT DENIED DAMAGE AND MOISTURE TO THE PUMP. THE PATIENT STATED THAT THE BATTERY CAP WAS SECURE AND THE YELLOW O-RING WAS NOT VISIBLE. THE PATIENT STATED THAT HE ATTEMPTED TO TROUBLESHOOT AND WHEN THE PATIENT WOULD PRESS A BUTTON, THE PUMP WOULD DISPLAY A HOURGLASS, THEN FLASH. AND REPORTED THAT THE TIME/DATE VERIFY SCREEN WOULD COME ON. THE PATIENT REPORTED THAT HE HAD A BLOOD GLUCOSE (BG) OF 340MG/DL WITH SORENESS, ACHINESS AND FATIGUED. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE PATIENT WAS TREATED WITH 8 UNITS OF NOVOLOG VIA SYRINGE AND AFTER THREE HOURS BG WENT DOWN TO 107MG/DL. THIS REPORT IS BEING MADE DUE TO THE INTERMITTENT POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155200 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR