BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2918870 · Received January 16, 2013

    Report

    Report Number
    2531779-2013-00731
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 22, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. TESTING WAS UNABLE TO DUPLICATE THE COMPLAINT. PRIME HISTORY VERIFIES REPORTED PRIME VOLUMES. THERE ARE NO "PUMP NOT PRIMED" WARNINGS OR "CARTRIDGE DETECTED" WARNINGS OBSERVED IN THE BLACK BOX. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING CORRECT FORCE AT 5LBS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A CARTRIDGE WITH 100 UNITS WAS CORRECTLY LOADED INTO THE PUMP. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT. NO BURR WAS OBSERVED ON THE PISTON ROD.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT CONTACTED ANIMAS ALLEGING THE PAST TWO TO THREE DAYS HIS BLOOD GLUCOSE (BG) HAS BEEN LOWER THAN NORMAL, AROUND 70MG/DL. THE PATIENT STATED THAT HIS LAST SETTINGS ADJUSTMENT WAS SIX WEEKS AGO BY HIS HEALTHCARE PROVIDER. THE PATIENT STATED THAT ON (B)(6) 2012 HIS BG WAS 72MG/DL WITH DIZZINESS AND HE "FELT LOW". CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE PATIENT AND FOUND SEVERAL SMALL PRIME VOLUMES ASSOCIATED WITH CARTRIDGE CHANGES, INDICATING A POSSIBLE LOAD STEP MALFUNCTION. THE PATIENT CONFIRMED THAT HE DOES NOT MANUALLY PRIME THE TUBING AND WAITS TILL HE SEES DROPS COMING FROM THE TUBING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA POTENTIALLY RELATED TO A LOAD STEP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24503 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening