BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183036 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05422
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. PUMP INFORMATION FROM DATE OF PI HAS BEEN OVERWRITTEN. UNABLE TO CONFIRM COMPLAINT. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN BLACK BOX OR DOWNLOAD HISTORY. NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED HIGH BGS DUE TO CONTINUED USE.

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2011 ALLEGING THAT THE PATIENT'S BLOOD GLUCOSE HAS BEEN INTERMITTENTLY ELEVATED SINCE (B)(6) 2011. THE PATIENT'S BLOOD GLUCOSE READING WENT AS HIGH AS 525 MG/DL. THE PATIENT'S INFUSION SITE HAS BEEN CHANGED 8-9 TIMES WITHOUT SUCCESS IN PREVENTING THE PATIENT'S BLOOD GLUCOSE INTERMITTENT HIGH BLOOD GLUCOSE. THE PATIENT WAS GIVEN INSULIN VIA SYRINGES TO LOWER HER BLOOD GLUCOSE. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR MEDICAL INTERVENTION AT THE TIME OF CONCERN. DURING THE CALL TO ANIMAS, THE REPORTER WANTED TO MAKE SURE THE ANIMAS WAS FUNCTIONING CORRECTLY. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE COULD NOT FIND ANY ISSUE WITH THE ANIMAS PRODUCT. THE ANIMAS WAS SET WITH THE CORRECT DATE AND TIME, BASAL SEGMENT, AND ADVANCE FEATURES. THE SUBJECT PUMP WAS ABLE TO DELIVER AIR BOLUS AS PROGRAMMED. THERE WAS NO ALARM IN (B)(6) EXCEPT FOR THE LOW/EMPTY CARTRIDGE. ALL BOLUS INSULIN WAS ACCOUNTED FOR AND DELIVERY APPROPRIATELY. THE TOTAL DAILY DOSE OF INSULIN ADDED UP CORRECTLY. THE BASAL INSULIN DELIVERED ON TIME AS PROGRAMMED. THE PUMP WAS NOT SELF SUSPENDING. THERE WERE NO ISSUES FOUND WITH THE INFUSION SET, THE SITE, AND THE CARTRIDGE. THE INFUSION SET AND THE CARTRIDGE DID NOT HAVE ANY AIR BUBBLES OR LEAKAGE. THE PATIENT'S INFUSION SITE WAS NOT RED, LUMPY, OR HARD. THE REPORTER WILL FOLLOW-UP WITH THE PATIENT'S DOCTOR FOR FURTHER CLINICAL RECOMMENDATION. THE SUBJECT PUMP WILL NOT BE RETURN FOR INVESTIGATION. IT IS NOT KNOWN WHAT IS CONTRIBUTING TO THE PATIENT'S ALLEGED HYPERGLYCEMIA. THERE WAS NO CHANGE IN THE PATIENT'S HEALTH CONDITION, ACTIVITY, OR DIET. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD ELEVATED BLOOD GLUCOSE OF 525 MG/DL WHILE HER DIABETES WAS MANAGED WITH THE ANIMAS PUMP.

    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 2 YR Life Threatening