BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243951 · Received November 25, 2008

    Report

    Report Number
    2939301-2008-03258
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 13, 2008
    Manufacturer
    LIFESCAN, INC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/REPORTER (THE PATIENT'S WIFE) CALLED LIFESCAN (LFS) IN 2008 ON BEHALF OF THE LAY USER/PATIENT AND ALLEGED THAT A ONETOUCH ULTRA METER WAS GIVING HIM INACCURATE HIGH RESULTS. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PATIENT'S WIFE; HOWEVER WAS ONLY ABLE TO OBTAIN PARTIAL INFO PRESENTED BELOW. THE PATIENT'S WIFE WAS UNWILLING TO PROVIDE ADDITIONAL INFO. ON EIGHT DAYS EARLIER AT UNK TIME IN THE NIGHT, THE PATIENT WAS EXPERIENCING 'STROKE LIKE SYMPTOMS". THE REPORTER WAS UNWILLING TO PROVIDE INFO ABOUT SPECIFIC SYMPTOMS THAT HE WAS EXPERIENCING. THE EMERGENCY MEDICAL SERVICE (EMS) WAS CALLED. THEY FIRST TESTED THE PATIENT'S BLOOD SUGAR ON THE ALLEGED METER AND RECEIVED A RESULT OF 174 MG/DL. THE THOUGHT THAT THE PATIENT WAS EXPERIENCING "STROKE". HE WAS TAKEN ON THE AMBULANCE AND HIS BLOOD SUGAR WAS TESTED ON ANOTHER, AMBULANCE'S METER AND REPORTEDLY RECEIVED A RESULT OF 44 MG/DL. THE REPORTER WAS UNWILLING THE PROVIDE INFO ON TREATMENT PROVIDED TO HIM. SHE STATED THAT THE DOCTOR MENTIONED THAT THE REASON FOR THE PATIENT EXPERIENCING THE ALLEGED SYMPTOMS WAS THAT HE PROBABLY DID NOT EAT ENOUGH OR TOOK HIGHER AMOUNT OF HUMALOG INSULIN. THE REPORTER WAS ALSO UNWILLING TO STATE WHAT KIND OF BLOOD SUGAR RESULTS DID HE RECEIVE ON THE REPORTED METER AND HOW MUCH INSULIN DID HE TAKE PRIOR TO DEVELOPING THE ALLEGED SYMPTOMS. THE REPORTER WAS UNWILLING TO PROVIDE INFORMATION WHETHER THE PATIENT WAS USING CORRECT TECHNIQUE TO TEST AND TO CLEAN THE PUNCTURE AREA OR NOT, WHETHER THE SAMPLE WAS COLLECTED FROM A RECOMMENDED SITE OR NOT, AND WHETHER THE METER WAS SET TO CORRECT UNIT OF MEASURE OR NOT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED, AS THE PATIENT ALLEGEDLY RECEIVED HIGH BLOOD SUGAR READING ON THE REPORTED METER AND OBTAINED A RESULT OF '44 MG/DL' AFTER THE PRODUCT ISSUE AND ALLEGEDLY REQUIRED THE ASSISTANCE OF THE EMS. DIABETES CARE MANAGEMENT: THE PATIENT NORMALLY TESTS HIS BLOOD SUGAR TWO TIMES DAILY. HE TAKES UNK ORAL MEDICATION AND HUMALOG INSULIN TO MANAGE HIS DIABETES. HE ADJUSTS DOSAGE OF HUMALOG INSULIN BASED ON HIS BLOOD SUGAR READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC NA 2753546

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R