BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3163670 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08110
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/08/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/16/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY SHOWS AN UNCONFIRMED ¿REPLACE BATTERY¿ ALARM ON 05/18/2013 AT 08:05. THE BATTERY VOLTAGE AT THE TIME OF THE ALARM WAS LOW AND THE UNCONFIRMED ALARM COMPLETELY DISCHARGED THE BATTERY, AT WHICH TIME THE PUMP BEGAN TO CONTINUOUSLY REBOOT. THE BATTERY COMPARTMENT AND CAP WERE RETURNED INTACT. DURING TESTING, THE PUMP POWERED ON APPROPRIATELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OCCURRING. DURING INVESTIGATION, THE PUMP WAS OPENED AND NO INTERNAL DAMAGE WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION; HOWEVER, PRODUCT INVESTIGATION HAS NOT BEEN COMPLETED. ONCE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CLAIMED THE ANIMAS INSULIN PUMP HAS POWER ISSUES. THE PATIENT REPLACED THE PUMP WITH 3 NEW BATTERIES. WHEN HE AWOKE, THE SUBJECT PUMP LOST POWER UP. THE SUBJECT PUMP DID NOT HAVE PHYSICAL DAMAGE OR MOISTURE WITHIN. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263747 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR