BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2832994 · Received November 15, 2012

    Report

    Report Number
    2531779-2012-13622
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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. ALARM HISTORY VERIFIES AN OCCLUSION ALARM ON (B)(6) 2012; NO DATA IN THE BLACK BOX FROM THIS TIME DUE TO CONTINUED USE. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. AN OCCLUSION WAS INDUCED AND THE PUMP GIVES THE APPROPRIATE VISUAL AND AUDIBLE "OCCLUSION DETECTED NO DELIVERY" ALARM.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THE FOLLOWING SEQUENCE OF EVENTS: HE AWOKE THE MORNING OF (B)(6) 2012 WITH ELEVATED BLOOD GLUCOSE (BG) IN THE 400'SMG/DL. HE HAD A LARGE AMOUNT OF KETONES. HE CONTINUED TO BOLUS THE ENTIRE DAY THROUGH THE SITE AND BG WOULD NOT COME DOWN. WHEN PATIENT REMOVED HIS SITE, STATES CANNULA WAS 'Z' SHAPED. HE IS UPSET THAT HE DID NOT GET ANY INSULIN AND THAT THE PUMP DIDN'T ALERT HIM. HE HAD CHANGED HIS SITE AND CONTINUED ON PUMP. HE WAS EVALUATED IN THE EMERGENCY ROOM (ER) THE EVENING OF (B)(6) 2012. HE WAS GIVEN IV FLUIDS AND IV INSULIN AND REMAINED SEVERAL HOURS IN ER. HE WAS DISCHARGED HOME AFTER BG CAME DOWN. HE CONTINUED WEARING INSULIN PUMP. HE IS EXTREMELY UPSET OVER THIS ISSUE AS HE HAS HAD DIABETES FOR 40 YEARS AND HAS NEVER HAD A COMPLICATION LIKE THIS, STATES HE HAS NEVER HAD A LARGE AMOUNT OF KETONES. CUSTOMER SERVICE REVIEWED ALARM HISTORY AND THERE WAS 1 OCCLUSION ALARM RECORDED ON (B)(6) 2012 AT 6:18AM. REVIEWED OCCLUSION SENSITIVITY, IN PUMP WAS SET TO LOW. THE PATIENT HAD GIVEN 15 BOLUSES ON (B)(6) FROM 3:18AM TO 9:06 PM- ALL BOLUSES SAY COMPLETED. THE PATIENT STATES HE DOES NOT TRUST THIS PUMP AND DOES NOT FEEL SAFE USING IT. THE PATIENT REMAINS ON THE PUMP UNTIL A REPLACEMENT ARRIVES. THIS ISSUE IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP FAILED TO EMIT AN OCCLUSION ALARM AND THAT THE PATIENT REQUIRED MEDICAL ATTENTION FOR AN EPISODE OF HYPERGLYCEMIA WITH LARGE KETONES.

    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 63 YR Required Intervention