BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2102779 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03688
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    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. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THERE ARE NO ALARMS RELATED TO THE COMPLAINT IN THE PUMP ALARM HISTORY; A REVIEW OF THE TOTAL DAILY DOSE SHOWED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATE AFTER THE REPORTED EVENT DATE. A REVIEW OF THE BLACK BOX SHOWED TYPICAL USAGE ALARMS AND WARNINGS; TIME AND DATE RESETS WERE NOTED IN THE BLACK BOX AFTER A REBOOT. THE PUMP WAS EXERCISED FOR 29HRS WITH NO DIFFICULTIES DUPLICATED; A FLOW ACCURACY TEST WAS ALSO PERFORMED WITH THE PUMP FOUND TO BE DELIVERING ACCURATELY. THE PUMP WAS POWERED OFF FOR APPROXIMATELY ONE HOUR DURING WHICH THE TIME AND DATE RESET TO FACTORY DEFAULT SETTINGS. PUMP WAS DISASSEMBLED AND OBSERVED LEAKING BACKUP BATTERY AT BT1 LOCATION ON THE (B)(6). 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

    THE PATIENT REPORTED EXPERIENCING BLOOD GLUCOSE (BG) OVER 600 MG/DL AND BEING GIVEN INTRAVENOUS FLUIDS IN THE EMERGENCY ROOM (ER) ON (B)(6) 2011. SHE STATED THAT SHE LEFT THE HOSPITAL AND WANTED TO RESOLVE THE HIGH BG ON HER OWN AT HOME. THE PATIENT DID NOT REPORT PRESENCE OF SYMPTOMS OR KETONES. SHE STATED THAT SHE CHANGED THE INSERTION SITE AND GAVE A CORRECTION BOLUS, AND STATED THAT HER BG RESOLVED TO 313 MG/DL. THE PATIENT DID NOT WANT TO REVIEW THE PUMP SETTINGS AND THE INSULIN DELIVERY HISTORY AT THE TIME OF THE CALL TO ANIMAS CUSTOMER SUPPORT (CS). SHE STATED THAT HER REASON FOR CONTACTING CS WAS TO OBTAIN INFORMATION REGARDING BOLUS CALCULATIONS AND THE INSULIN ON BOARD FEATURE (IOB). THE PUMP IS NOT BEING RETURNED AT THIS TIME, AND THE PATIENT HAS CONTINUED USING THE PUMP WITHOUT FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING THE PUMP.

    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 49 YR Hospitalization