BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEVICE

    MDR report key: 2103159 · Received May 25, 2011

    Report

    Report Number
    2939301-2011-04385
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 LFS ON (B)(6) 2011, ALLEGING THAT HER LANCING DEVICE WAS CRACKED/BROKEN. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. THE FOLLOWING IS BASED ON THE INITIAL CALL PLACED BY THE PATIENT. THE PATIENT MENTIONED THAT SHE FIRST NOTICED THAT HER LANCING DEVICE CASING WAS CRACKED/BROKEN ON (B)(6) 2011. THE PATIENT HAS HAD THE LANCING DEVICE 4-5 YEARS PRIOR TO THE ALLEGED ISSUE WITH THE LANCING DEVICE. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED AND RECEIVED MEDICAL TREATMENT; HOWEVER, IT IS UNKNOWN WHY THE PATIENT WAS HOSPITALIZED AND WHAT KIND OF TREATMENT THE PATIENT RECEIVED. BASED ON THE INITIAL REPORT THERE WAS NO MISUSE OF THE PRODUCT. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, HOW LONG THE PATIENT WAS UNABLE TO TEST, CONFIRM ABOUT WHETHER THE PATIENT DEVELOPED SYMPTOMS, WHY THE PATIENT AS HOSPITALIZED, INITIAL READING IN THE HOSPITAL, TREATMENT SHE RECEIVED AND HOW LONG SHE WAS HOSPITALIZED. PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO A CRACKED/BROKEN CASING SHE WAS UNABLE TO TEST AND ENDED UP BEING HOSPITALIZED AND RECEIVING TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R