BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METER

    MDR report key: 1822540 · Received September 1, 2010

    Report

    Report Number
    2939301-2010-07482
    Event Type
    Injury
    Date Received
    September 1, 2010
    Report Date
    August 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    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

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER LFS METER WAS READING INACCURATELY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON AN UNSPECIFIED DATE/TIME IN (B)(6) 2009. ACCORDING TO THE CSR DOCUMENTATION, THE PATIENT DOES NOT KNOW WHAT TYPE OF METER SHE WAS USING. THE PATIENT ALSO DID NOT SPECIFY THE ALLEGED INACCURATE RESULT SHE OBTAINED WITH THE SUBJECT METER. IT IS NOT KNOWN AS TO THE TYPE OF ORAL REGIMEN THE PATIENT IS ON TO MANAGE HER DIABETES; HOWEVER, IN RESPONSE TO THE ALLEGED ISSUE THE PATIENT CONSUMED HER MEDICATION (TIME NOT SPECIFIED). TWO HOURS AFTER THE ALLEGED ISSUE BEGAN THE PATIENT CLAIMED SHE PASSED OUT. THE PATIENT CLAIMED SHE ADMINISTERED SELF TREATMENT ON (B)(6) 2009; HOWEVER, THE TIME AND TYPE OF TREATMENT ARE NOT SPECIFIED. IT IS ALSO NOT KNOWN IF THE PATIENT TESTED WITH ANOTHER DEVICE AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE PATIENT REFUSED TO CONTINUE WITH THE CALL AND DISCONNECTED WITH THE CSR. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED 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 56 YR Life Threatening