BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1051826 · Received May 23, 2008

    Report

    Report Number
    2939301-2008-00916
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED. LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE DIABETES CASE MANAGER/HEALTHCARE PROVIDER CONTACTED LIFESCAN ON BEHALF OF THE LAY-USER/PT WANTING TO KNOW IF INCORRECT CODING OF THE ONE TOUCH ULTRA2 COULD GIVE INACCURATE LOW READINGS. ON MAY 15, 2008, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE DIABETES CASE MANAGER TO OBTAIN MORE INFO FROM THE INITIAL CALL. THE DIABETES CASE MGR. WAS CONCERNED THAT THE PT REPORTEDLY HAD READINGS OF "122,122, AND 126 MG/DL" ON THE LFS METER PRIOR TO BEING ADMITTED TO THE HOSPITAL AND WAS TESTED AT "702 MG/DL" ON A LAB INSTRUMENT. ACCORDING TO THE HCP, THE PT IS A TYPE 1 DIABETIC AND REPORTEDLY HAS BEEN "NON COMPLIANT" WHEN IT COMES TO TREATING HER DIABETES. REPORTEDLY, THE PT WAS TAKING HER USUAL INSULIN MEDICATION REGIMEN (18 U OF NPH DURING THE DAY, 11 U OF REGULAR, AND 19 U OF NPH IN THE EVENING) PRIOR TO BEING HOSPITALIZED. THE PT WAS HAVING HYPERGLYCEMIC SYMPTOMS DESCRIBED AS "LETHARGIC AND WAS HAVING A HARD TIME WAKING UP" ON THE DAY PRIOR TO ORIGINAL DATE. THE DURATION OF HER SYMPTOMS LASTED UNTIL SHE WAS EVENTUALLY ADMITTED INTO THE HOSPITAL ON ORIGINAL DATE AT NOON. THE PT'S MOTHER CLAIMED SHE WAS UNAWARE THAT THE PT WAS EXPERIENCING HYPERGLYCEMIC SYMPTOMS SINCE THE PT OBTAINED READINGS OF "122, 122, AND 126 MG/DL" THE LFS METER AT THE TIME OF CONCERN, THOSE DAYS. THE PT'S MOTHER THOUGHT THE PT WAS HAVING THE FLU. ON ORIGINAL DATE, THE PT'S SYMPTOMS GOT PROGRESSIVELY WORSE AS THE PT STARTED TO VOMIT. THE PT'S MOTHER TOOK HER TO A CLINIC WHERE THE PT WAS LATER TRANSPORTED TO THE EMERGENCY ROOM AND WAS TESTED AT "702 MG/DL." THE PT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND ELECTROLYTE IMBALANCE. THE PT WAS ADMITTED INTO THE HOSPITAL ON THE SAME DAY, AT NOON WHERE SHE STAYED FOR 4 DAYS AND WAS TREATED WITH IV FLUIDS. THE PT'S DIABETES MEDICAL REGIMEN AND TESTING FREQUENCY HAS NOT BEEN CHANGED AFTER THE REPORTED INCIDENT. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE REQUESTED THAT THE HEALTHCARE PROVIDER HAVE THE PT CONTACT LIFESCAN WITH THE COMPLAINT FOR DETAIL INFO IN REGARDS TO THE INACCURATE LOW READINGS, METER SERIAL NUMBER, AND LOT# OF TEST STRIPS. AT THIS POINT, THERE IS NO FURTHER INFO THAT CAN BE GATHERED DUE TO PT INFO CONFIDENTIALITY. THIS COMPLAINT IS BEING REPORTED BECAUSE IT IS CLAIMED THAT THE PT OBTAINED INACCURATE LOW READINGS FROM HER METER AND LATER HAD TO BE TREATED FOR DIABETIC KETOACIDOSIS IN A HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R