BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1832767 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07806
    Event Type
    Injury
    Date Received
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    THE 510 (K) # IS K062195.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY WAS TO BE USED DURING A BIOPSY PROCEDURE ACCORDING TO THE COMPLAINANT, AFTER REMOVING THE DEVICE FROM THE PRODUCT PACKAGING, WHILE PREPARING FOR THE PROCEDURE, THE CLEVIS HEAD WAS FOUND TO BE BENT. THE ACCOUNT REPORTED THAT NO DAMAGE WAS VISIBLE TO THE PACKAGING AND THE STERILE BARRIER HAD NOT BEEN COMPROMISED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ON SEPTEMBER 13, 2010, THE LAY-USER/PATIENT ALLEGED THAT A ONE TOUCH ULTRA METER HAD AN "ER" ISSUE WHILE SPEAKING TO A MEDICAL SURVEILLANCE SPECIALIST (MSS). THE PATIENT TESTS HER BLOOD GLUCOSE TWICE A DAY. SHE MANAGES HER DIABETES WITH ORAL MEDICATIONS AND INSULIN. IT IS UNKNOWN WHAT DATE/TIME THE ALLEGED ISSUE BEGAN. THE PATIENT ALLEGED THAT WHENEVER SHE INSERTED A TEST STRIP INTO THE METER, THE DEVICE DISPLAYED AN "ER" MESSAGE. THE PATIENT COULD NOT RECALL WHAT SPECIFIC ERROR MESSAGE OR NUMBER APPEARED. THE PATIENT CLAIMED THAT SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE "FOR SOME TIME" DUE TO THE REPORTED ISSUE AND AS A RESULT, SHE ALLEGEDLY DEVELOPED SYMPTOMS OF SHAKINESS AND AGITATION. THE PATIENT DENIED THAT SHE RECEIVED TREATMENT BECAUSE OF THE ALLEGED ISSUE. THE METER AND TEST STRIPS WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening