BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2110953 · Received June 2, 2011

    Report

    Report Number
    2531779-2011-03864
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERS ON NORMALLY WITH NO ALARMS. THERE WAS NO EVIDENCE OF POWER ISSUES OR ACTIVITY OUTSIDE NORMAL USE NOTED IN THE PUMP HISTORY. THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP, BATTERY COMPARTMENT, OR TO THE POWER CIRCUIT. THE BATTERY CAP SECURED PROPERLY TO THE PUMP DURING TESTING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER ISSUES OCCURRING.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND 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 BLOOD GLUCOSE (BG) BETWEEN 400 AND 600 MG/DL WITH ABDOMINAL PAIN. THE PATIENT'S BG RESOLVED WITH CORRECTION BY PUMP AND SYRINGE. SHE REPORTED THAT THE PUMP WAS INTERMITTENTLY LOSING POWER. THE PATIENT REPORTEDLY STARTED ON A REPLACEMENT PUMP AND BG HAS BEEN NORMAL. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA AFTER THE PUMP INTERMITTENTLY LOST POWER.

    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 9 YR