BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2122445 · Received June 13, 2011

    Report

    Report Number
    2531779-2011-04111
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    April 24, 2011
    Report Date
    May 15, 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 PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. 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 REPORTER CLAIMED THAT THE PATIENT HAS HAD LARGE PRIME VOLUME ISSUES 4 TIMES (B)(6). AFTER THE LARGE PRIMING ISSUE BEGAN, THE PATIENT REPORTEDLY ELEVATED BLOOD GLUCOSE ON (B)(6) 2011 AND (B)(6) 2011. IN ADDITION, THE PATIENT WAS TREATED IN THE PEDIATRIC ICU WITH IV FLUIDS AND EVENTUALLY DISCHARGED ON (B)(6). THE PATIENT REPORTEDLY RESUMED DIABETES MANAGEMENT WITH THE ANIMAS INSULIN PUMP AFTERWARD. HER BLOOD GLUCOSE IS CURRENTLY BETTER CONTROLLED AS HER LAST BLOOD GLUCOSE READING WAS AT 148 MG/DL ON THE DAY OF THE CALL TO ANIMAS. DURING TROUBLESHOOTING, THE REPORTER NOTED THE FOLLOWING: THE PATIENT SAFELY DISCONNECTED FROM THE INSULIN SITE DURING TROUBLESHOOTING. THE CORRECT TECHNIQUE WAS USED TO LOAD THE CARTRIDGE BUT THE ISSUE IS NOT RESOLVED WITH TRAINING. THE PRIMING ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. ALTHOUGH THERE IS NO EVIDENCE OF A PRODUCT MALFUNCTION, THERE IS NO EVIDENCE THAT THE ANIMAS PRODUCT CONTRIBUTED TO A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION SUGGESTIVE OF HYPERGLYCEMIA POSSIBLY DUE TO A USER ERROR.

    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 5 YR Life Threatening| R