BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2374542 · Received December 14, 2011

    Report

    Report Number
    2531779-2011-09293
    Event Type
    Injury
    Date Received
    December 14, 2011
    Report Date
    November 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. THE PATIENT USED COLD INSULIN AND DOES NOT CYCLE THE CARTRIDGE, WHICH MAY HAVE CONTRIBUTED TO HER BLOOD GLUCOSE ELEVATIONS. THE OWNER'S BOOKLET STATES TO ALWAYS FILL THE CARTRIDGE WITH ROOM TEMPERATURE INSULIN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 10/16/2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE CURRENT PUMP HISTORY SHOWS NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE; NO ACTIVITY RELATED TO THE COMPLAINT WAS OBSERVED THE DELIVERED BOLUSES AND BASALS ADD UP CORRECTLY AND TOTAL THE DAILY INSULIN DELIVERY RATE. THE PUMP SUCCESSFULLY COMPLETED THE REQUIRED 29HR FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2012 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.

    Description of Event or Problem · 1

    THE USER SAID HER BLOOD GLUCOSE LEVELS HAVE BEEN 500 TO 800 MG/DL FOR OVER A WEEK STARTING NOVEMBER 14. THE PATIENT USUALLY ROTATES INFUSION SITES ON HER ABDOMEN BUT HER HCP REPORTED SEVERE SCAR TISSUE AT INFUSION SITES AND RECOMMENDED SHE USE HER THIGH AS AN INFUSION SITE. THE PATIENT REPORTED SEVERE LEG SPASMS AND CRAMPS AND THE BLOOD GLUCOSE LEVELS RAN HIGH DURING THOSE TIMES. SHE WENT OFF OF PUMP THERAPY ON NOVEMBER 18 AND STARTED A MANUAL INSULIN INJECTION REGIME. SHE SAID THAT SHE HAD GOTTEN A CS ALARM ON NOVEMBER 18 AND SAW A LARGE POCKET OF AIR IN HER CARTRIDGE WHEN SHE REMOVED IT ON NOVEMBER 18. THE PATIENT DOES NOT CYCLE THE PLUNGER OF THE CARTRIDGE PRIOR TO FILLING AND USES COLD INSULIN MOST OF THE TIME TO FILL THE CARTRIDGE. HER BLOOD GLUCOSE LEVELS REMAINED ELEVATED AT 230-346 MG/DL AROUND THE TIME SHE CALLED ANIMAS. ON THE TROUBLESHOOTING TELEPHONE CALL THE PATIENT PRIMED THE PUMP TWICE AND NO INSULIN CAME OUT OF THE TUBING. THE CS 064 ALARM APPEARED ON THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT¿S BLOOD GLUCOSE WAS ELEVATED WHILE ON 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 51 YR