BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2923789 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-00922
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    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: MULTIPLE "OCCLUSION" ALARMS WITH HIGH FORCE ARE OBSERVED IN THE BLACK BOX AND ALARM HISTORY ON THE REPORTED FAILURE DATE CAUSING DELIVERY INTERRUPTIONS. CAUSED "OCCLUSION" BY CLAMPING OFF INFUSION TUBING, AND THE PUMP GAVE THE APPROPRIATE VISUAL AND AUDIBLE ALERT. TOTAL DAILY INSULIN DELIVERIES ADD UP CORRECTLY AND REFLECT THE USER'S PROGRAMMED BASAL RATES. PUMP POWERS UP NORMALLY, PERFORMED "EZ-PRIME" STEPS SUCCESSFULLY. PUMP WAS EXERCISED FOR 24 HRS, NO ALARMS DUPLICATED DURING TESTING. THE FORCE SENSOR CALIBRATION READING IS WITHIN SPECIFICATION. THE PUMP PASSES A 29 HOUR FLOW ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. OPENED THE PUMP TO INVESTIGATE, NO DAMAGE WAS FOUND TO THE FORCE SENSOR .THE DRIVE ASSEMBLY WAS DISASSEMBLED AND THE LEAD SCREW THREADS WERE FOUND TO BE CONTAMINATED.

    Description of Event or Problem · 1

    ON (B)(6) 2012,THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT DUE TO REPEATED OCCLUSION ALARMS, HE CHANGED OUT HIS DAUGHTER'S COMPLETE SITE/SET/CARTRIDGE USING UNEXPIRED CARTRIDGE, CYCLING 2 TO 3 TIMES, INSERTING INFUSION SET INTO A GOOD SITE. OCCLUSIONS ALARMS CONTINUED. THE PATIENT'S BLOOD GLUCOSE (BG) ROSE INTO THE 500MG/DL RANGE AND SHE BEGAN SEVERE VOMITING AND KETONES WERE LARGE. FATHER CALLED A HEALTH CARE PROVIDER (HCP), GAVE INJECTIONS OF INSULIN AS DIRECTED BY HCP, AND THE VOMITING STOPPED AND KETONES STARTED DROPPING. HE REMOVED THE PUMP, STARTED A BACK UP PUMP, AND HER BGS ARE NOW DOWN IN THE NORMAL RANGE. THE VOMITING STOPPED, AND NO MORE OCCLUSION ALARMS OCCURRED. FATHER REPORTS HE HAS LOST CONFIDENCE IN THIS PUMP AND IS REQUESTING IT BE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON INSULIN PUMP THERAPY EXPERIENCED HYPERGLYCEMIA RELATED TO A PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30868 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening