BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 3140038 · Received May 31, 2013

    Report

    Report Number
    3008382007-2013-14036
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 13, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/22/2013)- CORRECTION: THE CORRECT BRAND NAME OF THE PRODUCT INVOLVED IN THE REPORTED ISSUE IS THE ONETOUCH LANCING DEVICE AND NOT ONETOUCH ULTRASOFT LANCING DEVICE AS PREVIOUSLY NOTED. THE PRODUCT INVOLVED WITH THIS COMPLAINT (ONETOUCH LANCING DEVICE), HAS BEEN RETURNED ON (B)(4), 2013; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (09/10/2013).THE PATIENT¿S LANCING DEVICE HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/7/2013 AND 9/4/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE LANCING DEVICE PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS 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

    ON (B)(6) 2013, THE LAY USER/PATIENT¿S CARE TAKER (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING A COCKING CONTROL ISSUE, SPECIFYING THAT THE LANCET IN THE PATIENT¿S ONETOUCH ULTRASOFT LANCING DEVICE DOES NOT RETRACT. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED FROM THE REPORTER DURING A FOLLOW-UP CALL BY A CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER INDICATED THE ALLEGED PRODUCT ISSUE WAS DISCOVERED ON (B)(6) 2013, AT 10AM. JUST PRIOR TO OBSERVING THE ALLEGED LANCING DEVICE ISSUE, THE REPORTER CLARIFIED THAT THE PATIENT WAS ABLE TO TEST WITH THE SUBJECT LANCING DEVICE AND OBTAIN A BLOOD GLUCOSE RESULT WITH THEIR METER. THE REPORTER DOES NOT RECALL THE RESULT OBTAINED WITH THE PATIENT¿S METER; HOWEVER, STATED THE RESULT WAS NORMAL. AS A RESULT OF THE ALLEGED LANCING DEVICE ISSUE, THE PATIENT REPORTEDLY WAS UNABLE TO LATER TEST HER BLOOD GLUCOSE AND SUBSEQUENTLY THE REPORTER CONFIRMED, THE PATIENT DEVELOPED SYMPTOMS OF ¿CONFUSION, SWEATING, DROWSY¿ AT AN UNSPECIFIED TIME AFTERWARDS. THE REPORTED CONFIRMED THE PATIENT WAS ADMINISTERED GLUCOSE GEL AS TREATMENT AND SHE FELT BETTER APPROXIMATELY 30 MINUTES LATER. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT LANCING DEVICE FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE LFS PRODUCT. THE PRODUCT ISSUE REMAINS UNRESOLVED. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242366 ONE TOUCH LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R