BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METER

    MDR report key: 2436404 · Received February 2, 2012

    Report

    Report Number
    2939301-2012-01238
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    January 16, 2012
    Report Date
    January 16, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE LAY USER / PATIENT CONTACTED LIFESCAN ON (B)(6) 2012 ALLEGING THAT THEIR METER WOULD NOT POWER ON. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE INITIAL CALL. THE PATIENT CONTACTED LFS ALLEGING THAT HER LFS METER WOULD NOT POWER ON. THE PATIENT DID NOT KNOW THE NAME OF HER METER AND DID NOT HAVE HER METER AVAILABLE TO PROVIDE THE SERIAL NUMBER. THE PATIENT MENTIONED THAT ON (B)(6) 2011 AROUND MIDNIGHT SHE ATTEMPTED TO TEST AND HER METER WOULD NOT POWER ON. SHE DENIED EXHIBITING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. SHE WENT AND TOOK HER USUAL DOSAGE OF MEDICATION, ON (B)(6) 2012 AT 11:00AM, SHE VISITED HER PHYSICIAN AND WAS TESTED ON THE PHYSICIAN'S METER AND OBTAINED A 272 MG/DL AND WAS TREATED WITH 70 UNITS OF INSULIN. THE PATIENT DENIED EXPERIENCING ANY SYMPTOMS. SINCE THE PATIENT DID NOT HAVE THE SUBJECT METER AVAILABLE FOR TROUBLESHOOTING THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER NOT POWERING ON, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE FOR A COUPLE OF DAYS AND LATER WAS TREATED WITH INSULIN BY HER PHYSICIAN FOR A BLOOD GLUCOSE OF 272 MG/DL.

    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 Life Threatening| R