BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3002202 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02669
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/13/2013- 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 BLACK BOX HISTORY REVEALS INSTANCES OF UNACKNOWLEDGED ALARMS. AN UNCONFIRMED ¿LOW BATTERY¿ WARNING ON (B)(6) 2013 AT 1:44 COMPLETELY DISCHARGED THE BATTERY AND THE PUMP REBOOTED CONTINUOUSLY. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS AND NO POWER ISSUES OCCURRED. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND.

    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 WOKE UP THIS MORNING WITH A DEAD BATTERY. THE PATIENT STATED THAT HE PLACED A NEW BATTERY ON (B)(6) 2013 AND REPORTED THAT HE NOTED THE BARS LOWERING AND GOT A LOW BATTERY ALARM ON (B)(6) 2013. THE PATIENT STATED THAT HE CONFIRMED THE ALARM WENT TO BED AND THEN WOKE UP WITH THE PUMP NOT HAVING POWER. HE STATED THAT HE REPLACED THE BATTERY, CONFIRMED A LOW BATTERY ALARM, THERE WAS NO REPLACE BATTERY BEFORE THE POWER LOSS. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105675 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR