BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1832112 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07748
    Event Type
    Injury
    Date Received
    September 13, 2010
    Report Date
    August 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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.THE 510(K) # IS K061118.

    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 ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    (B)(4). THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE FAILED TESTING. ON PERFORMANCE TESTING WITH CONTROL SOLUTION THE RESULTS WERE FOUND TO FALL ABOVE THE LABELED RANGE. THEREFORE, THE COMPLAINT IS CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON AUGUST 22, 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELING/ NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON THE EVE OF (B)(6) 2010. THE PATIENT REPORTEDLY OBTAINED THE FOLLOWING READINGS: ON (B)(6) 2010 "152 MG/DL" (AT 8:30AM) AND "148 MG/DL" (AT 10:20PM) AND ON (B)(6) 2010 "162 MG/DL" (AT 8AM). IN ADDITION TO ORAL MEDICATION (TYPE AND DOSE UNSPECIFIED), THE PATIENT STATED SHE ALSO MANAGES HER DIABETES WITH DIET AND/OR EXERCISE; HOWEVER, IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE HAD LESS FOOD ON (B)(6) 2010 (TIME NOT SPECIFIED). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT EXPERIENCED SYMPTOMS OF SHAKING, LIGHTHEADEDNESS, AND JITTERY ON (B)(6) 2010 (TIME NOT SPECIFIED). THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, CONSUMED LESS FOOD AS A RESULT OF THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    ON (B)(6) 2010, COMPANY REPRESENTATIVE REPORTED INFUSION DEVICE WAS "NO LONGER WORKING," AND PT WAS IN THE HOSPITAL. NO ADDITIONAL DETAILS WERE GIVEN TO COMPANY REPRESENTATIVE, INCLUDING WHETHER HOSPITALIZATION WAS DUE TO COMPLAINT AGAINST INFUSION DEVICE. THREE FOLLOW-UP CALLS WERE MADE TO PT, BUT THESE WERE UNSUCCESSFUL. MESSAGES WERE LEFT TO CONTACT TECHNICAL SUPPORT. FOLLOW-UP LETTER WAS ALSO SENT. NO PRODUCT WILL BE RETURNED FOR EVAL AT THIS TIME.

    Description of Event or Problem · 1

    DURING HIP REPAIR PROCEDURE, PATIENT'S ARTICULAR CARTILAGE ON THE FEMORAL HEAD WAS DAMAGED BY THE SCOPE CANNULA WHEN INTRODUCED INTO THE JOINT. THE CHONDRAL DEFECT WAS NOT A FULL THICKNESS LESION, BUT MORE OF A SUPERFICIAL DEFECT. DR. CORRECTED THE DAMAGE TO THE ARTICULAR CARTILAGE BY DEBRIDING IT WITH A 4.5MM FULL RADIUS SHAVER, AS WELL AS AN ARTICULAR GLIDING PROBE. IT IS CONFIRMED THAT THE DEVICE WAS SHARPENED BY A 3RD PARTY REPAIR SHOP WHICH THE IFU CLEARLY STATES DON'T SEND TO 3RD PARTIES. THE CONDITION OF THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT MDS LIFESCAN INC. 3036382

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening