BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED METER

    MDR report key: 1040241 · Received May 7, 2008

    Report

    Report Number
    2939301-2008-00695
    Event Type
    Injury
    Date Received
    May 7, 2008
    Report Date
    April 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON APRIL 16, 2008, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH BASIC METER HAD AN "INSERT STRIP" ISSUE. THE PT TESTS HER BLOOD GLUCOSE TWICE A DAY. SHE TAKES SELF-ADJUSTED INSULIN (UNK TYPE). THE PT INDICATED THAT THE ALLEGED METER ISSUE STARTED IN 2008, AT 11:00 AM. THE PT DID NOT TAKE ANY ACTION RELATED TO DIABETES TREATMENT AS A RESULT OF THE REPORTED ISSUE. AT THE SAME TIME, THE ALLEGED ISSUE BEGAN, THE PT REC'D ASSISTANCE FROM EMERGENCY SVC. THE PT'S BLOOD GLUCOSE WAS TESTED ON A DR'S/CLINIC'S METER AND A RESULT OF "266 MG/DL" WAS OBTAINED. THE PT WAS TREATED WITH INSULIN (UNK TYPE AND DOSAGE). ALSO ON AN UNK DATE/TIME AFTER THE ALLEGED METER ISSUE BEGAN, THE PT REPORTEDLY DEVELOPED SYMPTOMS OF SWEATING AND DIZZINESS. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: HOW LONG THE PT HAD THE METER FOR, WHAT HER BLOOD GLUCOSE READING WAS ON THE METER, WHEN THE LAST RESULT WAS OBTAINED, AND WHAT ACTIONS THE PT TOOK IN RESPONSE TO THE ALLEGED ISSUE. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT DATE/TIME THE PT DEVELOPED THE SYMPTOMS AND WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED. THE ALLEGED METER ISSUE WAS RESOLVED WITH TROUBLESHOOTING. APPARENTLY, THE PT WAS NOT USING A CORRECT TECHNIQUE FOR TESTING WITH THE METER. THE METER AND CONTROL SOLUTION WERE REPLACED. ALTHOUGH THERE IS NO EVIDENCE THAT THE METER WAS NOT WORKING PROPERLY, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening