BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METER

    MDR report key: 2061587 · Received April 18, 2011

    Report

    Report Number
    2939301-2011-03149
    Event Type
    Injury
    Date Received
    April 18, 2011
    Report Date
    April 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    ON (B)(6) 2011 THE LAY USER/PATIENT'S SISTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S UNKNOWN ONETOUCH BRAND METER WAS DISPLAYING AN UNKNOWN/UNSPECIFIED MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT OR THE SISTER FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S SISTER REPORTED THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2011. THE PATIENT'S SISTER WAS NOT ABLE TO SPECIFY WHETHER THE PATIENT WAS TAKING ANY DIABETES MEDICATIONS OR TOOK ANY ACTION REGARDING HER DIABETES MANAGEMENT AT THE TIME THE ALLEGED ISSUE BEGAN. THE SISTER REPORTED THE PATIENT HAD SYMPTOMS OF SWEATING AND SHAKING; HOWEVER IT IS NOT KNOWN WHETHER THE SYMPTOMS STARTED BEFORE OR AFTER THE ALLEGED ISSUE BEGAN. AT AN UNKNOWN DATE/TIME, THE SISTER STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ASSISTANCE. AT THE TIME OF THE PATIENT'S HOSPITALIZATION, THE SISTER INDICATED THE PATIENT WAS TREATED WITH JUICE TO DRINK AND THEY HAD HER EAT "SOMETHING SWEET". THE SISTER INDICATED THE PATIENT TESTED ON ANOTHER BLOOD GLUCOSE DEVICE (UNKNOWN BRAND), BUT SHE WAS NOT ABLE TO RECALL THE RESULT OBTAINED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S SISTER CLAIMS THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE, REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, AND RECEIVED HCP INTERVENTION POSSIBLY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R