BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 528202 · Received June 2, 2004

    Report

    Report Number
    2939301-2004-03391
    Event Type
    Injury
    Date Received
    June 2, 2004
    Date of Event
    June 1, 2004
    Report Date
    June 1, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT'S CARETAKER HAD REPORTED THAT THE PT'S METER WAS READING INACCURATELY LOW. MEDICAL AFFAIRS SPECIALIST CALLED AND SPOKE WITH THE CARETAKER IN 06/2004, WHO PROVIDED ADDITIONAL INFORMATION. THE CARETAKER MENTIONED THAT THEY HAD BEEN NOTICING LOW READINGS ON THE PT'S METER FOR A FEW DAYS, BUT WAS NOT CONCERNED SINCE PT WAS "NOT SHOWING ANY SYMPTOMS." THE PREVIOUS DAY AT 9 AM, CARETAKER TESTED THEIR BLOOD GLUCOSE TWICE IN THE MORNING WITH A RESULT OF 29 MG/DL BOTH TIMES, CARETAKER THOUGHT THAT SOMETHING IS WRONG SINCE THE PT WAS "FEELING FINE AND WALKING" FOR A RESULT THIS LOW. CARETAKER CALLED THEIR DOCTOR WHO ADVISED THEM TO BE TAKEN TO THE E.R. BY 10:00 AM, PT WAS IN THE ER. THEIR BLOOD GLUCOSE RESULT ON THE ER METER WAS "700 SOMETHING." PATIENT WAS ASYMPTOMATIC AT THIS TIME ALSO. PT WAS IMMEDIATELY PLACED ON IV INSULIN AND RELEASED AFTER A FEW HOURS. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE PUNCTURE AREA WAS NOT BEING CLEANED CORRECTLY. ALSO, THE CARETAKER WAS WALKED THROUGH A CHECK STRIP TEST, WHICH WAS WITHIN RANGE. PT ONLY HAD ONE TEST STRIP LEFT IN THE VIAL. THE CARETAKER WAS WALKED THOUGH A CONTROL SOLUTION TEST, WHICH FAILED LOW OUTSIDE THE RANGE. CARETAKER WAS ADVISED TO RUN THE CONTROL SOLUTION TEST AGAIN WITH A TEST STRIP FROM A NEW VIAL. THE TEST PASSED AND IT WAS WELL WITHIN THE RANGE. THE TEST STRIPS ARE REPORTED IN GOOD CONDITION, NOT EXPIRED. PT IS ON A SLIDING SCALE REGIMEN WITH THEIR INSULIN MEDICATION. THE CARETAKER WAS IN A HURRY AND SO CARETAKER DID NOT PROVIDE THE SLIDING SCALE. CARETAKER DID MENTION THAT CARETAKER DID NOT GIVE PT ANY ADDITIONAL INSULIN FOR THE "PAST COUPLE OF DAYS" SINCE THEIR BLOOD GLUCOSE RESULTS ON THE METER WERE LOW. CARETAKER ALSO STATED THAT IF CARETAKER HAD KNOWN THAT THEIR BLOOD GLUCOSE LEVEL WAS NOT THAT LOW, CARETAKER WOULD NOT HAVE WITHHELD THEIR ADDITIONAL INSULIN DOSAGE PER THEIR SLIDING SCALE. THIS CASE IS REPORTED AS AN ADVERSE EVENT SINCE THE PT SUFFERED A SERIOUS INJURY WHERE THE METER AND STRIPS MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 243613A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L