BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091302 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03451
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Report Date
    April 23, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY DOSE HISTORY WAS REVIEWED FROM (B)(6) 2010 TO THE END OF PUMP USE ON (B)(6) 2011 AND THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP HISTORY SHOWS A 'REPLACE BATTERY' ALARM ON (B)(6) 2011 18:13. DURING INVESTIGATION, UNABLE TO REPRODUCE SECONDARY ERROR. THE PUMP ACCURATELY DELIVERS 2.00 UNITS/HR FOR 29-HR PERIOD. DHR REVIEW: DATE OF MANUFACTURE: 2009-11, SOFTWARE VERSION/REVISION: E3A, WITHIN SPECIFICATIONS WHEN RELEASED: YES, DISCREPANCIES IDENTIFIED: NO, COMMENTS: NO.

    Description of Event or Problem · 1

    ON (B)(6) 2011 IT WAS REPORTED THE PATIENT OBTAINED BATTERY ALARMS AND THEN NO POWER ON THE REPORTED PUMP. THE PATIENT REPLACED THE BATTERIES TO NO AVAIL; THE PUMP GAVE ALARMS AND THEN POWERED OFF. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS AND DID NOT SEEK ANY MEDICAL ATTENTION DUE TO THIS ISSUE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR