BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2962372 · Received February 14, 2013

    Report

    Report Number
    2531779-2013-01768
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS ON 10/10/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE BLACK BOX CONTAINS DATES FROM (B)(6) 2013. THE PUMP WAS USED AFTER THE ORIGINAL COMPLAINT DATE (B)(6) 2013 AND ALL HISTORIES AND BLACK BOX DATA FOR EVENT HAVE BEEN OVERWRITTEN. REVIEW OF THE AVAILABLE BLACK BOX AND ALARM HISTORY SHOW NO ERRORS OR ALARMS RELATED TO THE COMPLAINT. THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO CORRECTLY REFLECT THE USER'S PROGRAMMED BASAL RATES PUMP SUCCESSFULLY PASSED A 29HR FLOW ACCURACY 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 AND ALLEGED THAT HER BLOOD GLUCOSES (BG) HAVE BEEN RUNNING HIGH FOR ABOUT 10 DAYS, IN THE 300+ MG/DL RANGE, AND HIGH KETONES. SHE HAS INCREASED HER BASAL RATE 20% . SHE HAD RULED OUT SITE AND SET AND INSULIN HERSELF BEFORE THE CALL. THE PATIENT REPORTS SHE IS HAVING A STRANGE PAIN IN HER WRIST AND IS BEING TESTED FOR RHEUMATOID ARTHRITIS (RA), AND WOULD LIKE TO RULE OUT THE PUMP PRIOR TO SEEING THE RA SPECIALIST. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED PUMP AND FOUND NO ISSUES: NO ALARMS, THE BOLUS, BASAL, PRIME, AND SUSPENSION HISTORIES ARE CORRECT, AS WAS THE TOTAL DAILY DOSE. THE PATIENT IS CONTINUING ON THE PUMP, WILL MONITOR BG'S AND CONTINUE TO WORK WITH HEALTH CARE PROVIDER AND CALL BACK AS NEEDED. THERE IS NO INDICATION OF PUMP MALFUNCTION THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64552 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening