BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2132650 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04246
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/15/2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO PUMP DATA AVAILABLE FROM THE TIME OF THE EVENT DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THERE WAS ONE LOSS OF PRIME WARNING FOUND IN THE PUMP BLACK BOX ASSOCIATED WITH LOW NON-ZERO FORCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT LOSS OF PRIME OCCURRING. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND THE FORCE SENSOR WAS FOUND TO BE WITHIN CALIBRATION. THE PUMP WAS OPENED AND NO DAMAGE OR DEFECTS WERE FOUND THE FORCE SENSOR. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(6) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS. 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

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAS HAD ELEVATED BLOOD GLUCOSE (BG) VALUES SINCE CHANGING HIS INFUSION SET (B)(6), AND HIS BG AT THE TIME OF THE CALL TO CUSTOMER SUPPORT (CS) WAS READING 'HI" (OVER 600 MG/DL) ON THE METER. THE PATIENT STATED THAT HE RECEIVED OCCLUSION ALARMS AND LOSS OF PRIME WARNINGS THE MORNING OF THE INCIDENT WHEN HE ATTEMPTED TO DELIVER A BOLUS. CS INSTRUCTED THE PATIENT TO CHANGE THE INFUSION SET/SITE AND TO MONITOR HIS BGS; THE PATIENT WAS ADVISED TO CALL BACK IF THE ISSUE PERSISTED. THE PUMP IS NOT BEING RETURNED AT THIS TIME, AND THERE HAS BEEN NO FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 42 YR