BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3030958 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03435
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED 0.00 UNITS OUT OF A 2.15 UNIT BOLUS WAS DELIVERED ON THE EVENT DATE DUE TO A PARTIAL DELIVERY, USER ABORTED (PUMP) WARNING. A 1.10 UNIT BOLUS WAS THEN DELIVERED. THE TOTAL DAILY INSULIN DELIVERY TOTALS WERE REVIEWED AND CORRECTLY REFLECTED THE USERS PROGRAMMED BASAL RATES. ONLY TYPICAL USAGE WAS SHOWN IN THE PUMP¿S HISTORY FOR THE EVENT DATE. DURING TESTING, THE PUMP SUCCESSFULLY PASSED A (B)(4) ACCURACY TEST. THE COMPLAINT COULD NOT BE DUPLICATED DURING TEST. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THAT THE PATIENT HAS BEEN EXPERINCING BLOOD GLUCOSE (BG) VALUES IN THE 300MG/DL RANGE ALL WEEK. THE PATIENT REPORTEDLY HAS BEEN CHANGING OUT THE INFUSION SET EVERY DAY AND HIS BGS ARE STILL RUNNING HIGH. THE PATIENT DENIED BENT CANNULA. THERE WERE NO SITE/SET OR CARTRIDGE ISSUES NOTED. THE PATIENT REPORTEDLY DID NOT HAVE ANY NEW ILLNESS, WAS NOT ON NEW MEDICATION, DID NOT HAVE ANY NEW ACTIVITIES AND DID NOT HAVE ANY CHANGES IN DIET. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE REPORTER AND THERE WAS NO ISSUES NOTED WITH THE PROGRAMMING/SETTINGS ON THE PUMP. THE TOTAL DAILY DOSE WAS NOTED TO BE CORRECT AND ALL BOLUSES DELIVERED VIA THE PUMP WERE SUCCESSFULLY PERFORMED. NO ALARMS WERE NOTED IN PUMP HISTORY. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGATION OF A NONSPECIFIC PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135278 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR