BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3147462 · Received June 5, 2013

    Report

    Report Number
    2531779-2013-07759
    Event Type
    Injury
    Date Received
    June 5, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/02/2013 -DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A REVIEW OF THE PUMP HISTORY SHOWED THAT THE LAST BASAL AND BOLUS DELIVERIES OCCURRED ON 05/09/2013. A NORMAL 10UNIT BOLUS AND A 10UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED, AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD BUTTONS WERE TESTED AND NO HYPERSENSITIVITY WAS FOUND. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THERE WERE NO DELIVERY DEFECTS FOUND ON INVESTIGATION. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY, AND THE CONTRAST RETURNED TO NORMAL WITH NO SIGNS OF DISCOLORATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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) 2013, THE PATIENT CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: SHE HAD MODERATE CONFUSION TODAY AND YESTERDAY WITH BLOOD GLUCOSE (BG)S RANGING 200 - 370 MG/DL. SHE HAD MILD SHAKINESS YESTERDAY WITH BG IN 300 - 370 MG/DL RANGE. SHE HAD NOT CHECKED FOR KETONES AND DENIES ANY NAUSEA/VOMITING. PATIENT HAD CONTINUED USE OF PUMP UNTIL THIS AFTERNOON, BUT WAS CONCERNED ACCURACY, HER LAST BG TAKEN WITH WAS 191 MG/DL AND THE CONFUSION WAS NOT APPARENT AT THIS TIME. PATIENT REPORTS SHE CHECKED HER BG THIS MORNING, CHECKED IT AGAIN IT WAS DIFFERENT. BG YESTERDAY WAS 310 - 370MG/DL, DID NOT CHECK FOR KETONES, BUT WAS SLIGHTLY CONFUSED. PATIENT IS A POOR HISTORIAN AND CANNOT REMEMBER TODAY VERSUS TOMORROW. HUSBAND STATES SHE DID NOT EAT BREAKFAST YET TODAY. THE PATIENT WAS A LITTLE CONFUSED AND SHAKY BUT THE METER IS READING IN THE 200+MG/DL TODAY. PATIENT CANNOT REMEMBER IF SHE TOOK A BOLUS OR NOT. PUMP AND METER ARE PAIRED, SHE WANTED TO CHECK IT ON. PATIENT STATES SHE CHANGED HER BATTERY AND SITE/SET A FEW DAYS AGO. CS REVIEW FOUND RESULTS, DIFFERENT THAN WHAT PATIENT AND HUSBAND ARE REPORTING. THE PATIENT AND HUSBAND REPORT PATIENT CHANGES SITE/SET @ 5 DAYS, BUT THE INFORMATION IN PRIME HISTORY IS DIFFERENT INFORMATION. THE ALARM HISTORY INDICATES LAST ALARMS WERE IN (B)(6) 2012. THE PATIENT IS POOR HISTORIAN BUT THINKS THAT SHE HAS RECEIVED ALARMS SINCE NOVEMBER. CS WAS CONCERNED ABOUT THE SIGNIFICANT DIFFERENCE IN BASAL SETTINGS BETWEEN 8A - AND 10AM. REQUESTED THEY DISCUSS THIS SETTING WITH HER HCP TO BE SURE IT IS ACCURATELY PROGRAMMED. CS RECOMMENDED THAT PATIENT DISCONTINUE USE OF PUMP DUE TO HISTORY ISSUE. SHE WILL USE ALTERNATE INSULIN DELIVERY UNTIL REPLACEMENT IS RECEIVED. THIS COMPLAINT IS BEING REPORTED AS A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA POSSIBLY RELATED TO A HISTORY ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247756 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening