BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2110948 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03863
    Event Type
    Injury
    Date Received
    June 2, 2011
    Report Date
    May 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1, DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY DOSE HISTORY WAS REVIEWED FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 AND THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS' PROGRAMMED BASAL RATES. THERE WERE NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN THE PUMP HISTORY. THE PUMP ACCURATELY DELIVERS 2.00 UNITS/HR FOR 29-HR PERIOD. THERE WAS NO DEFECT FOUND DURING INVESTIGATION. DHR REVIEW: DATE OF MANUFACTURE: 2010-11, SOFTWARE VERSION/REVISION: E3A, WITHIN SPECIFICATIONS WHEN RELEASED: YES, DISCREPANCIES IDENTIFIED: NO, COMMENTS: NO.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OF 340MG/DL WITH VOMITING AND SHORTNESS OF BREATH. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL WITH A BG OF 491MG/DL, LETHARGY AND JAUNDICE, AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PUMP WAS REMOVED AND THE PATIENT WAS PLACED ON AN INTRAVENOUS (IV) INSULIN AND HER BG RESOLVED TO 102MG/DL. THE PATIENT WAS REMOVED FROM IV INSULIN AND PLACED BACK ON THE PUMP AND HER BG ELEVATED TO 464MG/DL. THE PATIENT WAS AGAIN REMOVED FROM THE PUMP AND PUT ON INSULIN INJECTIONS, AND HER BG WAS BETWEEN 240MG/DL AND 290MG/DL. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY WITH A FAMILY MEMBER AND THE FAMILY MEMBER CONFIRMED THAT THE BASAL PROGRAMMING IS CORRECT. A REVIEW OF THE BOLUS HISTORY REVEALED THAT THE BOLUS PROGRAMMING ADDS UP WITH THE TOTAL DAILY DOSE. THE FAMILY MEMBER CONFIRMED THAT THERE WERE NO SITE ISSUES. TROUBLESHOOTING INDICATED THAT THERE WERE NO MECHANICAL ISSUES WITH THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S HEALTHCARE PROFESSIONAL ALLEGED THAT THE PUMP MAY HAVE CAUSED OR CONTRIBUTED TO THE HYPERGLYCEMIC EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization