BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 1834033 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07891
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 20, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S LANCING DEVICE HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE LANCING DEVICE INVOLVED IN THIS CASE FAILED TESTING. FOUND THAT THE LANCET HOLDER CUP WAS DEFECTIVE. A SECONDARY ISSUE WAS ALSO NOTED AS CASING CRACKED/OPEN. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010 THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 101,373 JOULES. NO INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED TO AMERICAN MEDICAL SYSTEMS FOR EVAL.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE LANCET HOLDER ON THE ONETOUCH® LANCING DEVICE IS DAMAGED. THE PATIENT'S DIABETES IS MANAGED WITH ORAL MEDICATION. THE PRODUCT ISSUE BEGAN APPROXIMATELY ONE MONTH PRIOR TO CONTACTING LFS. THERE WAS NO ALTERATION TO THE PATIENT'S DIABETES MANAGEMENT AS A RESULT OF THE PRODUCT ISSUE. REPORTEDLY ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED AND TREATMENT WITH INSULIN FOR A BLOOD GLUCOSE READING OF "477 MG/DL" OBTAINED ON THE HOSPITAL METER. THE PATIENT ALLEGEDLY HAD SYMPTOM DESCRIBED AS "JERKING." IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION SUGGESTIVE FOR HYPERGLYCEMIA 1 MONTH AFTER THE PRODUCT ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R