BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1894573 · Received November 9, 2010

    Report

    Report Number
    2939301-2010-09780
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Report Date
    October 27, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/03/2010. 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

    FOLLOW-UP #2 (SUBMISSION 09/24/2012)-DEVICE EVALUATION: LIFESCAN RECEIVED THE TEST STRIPS INVOLVED WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(4) 2011. THE RETURNED TEST STRIPS FAILED TESTING. INVESTIGATION REVEALED THAT THE CONTROL SOLUTION TEST WITH THE RETURNED TEST STRIPS READ OUTSIDE THE EXPECTED RANGE. IT WAS ALSO NOTED THAT EXTRA TEST STRIPS WERE FOUND IN THE RETURNED TEST STRIP VIAL.

    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. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2010. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "104 AND 122 MG/DL" WITH THE SUBJECT METER AND "40 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF SOME OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IMMEDIATELY BEFORE THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SHAKY, SWEATY AND LIGHT HEADED. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO THIS SERIOUS INJURY. THE PATIENT FELT SYMPTOMATIC PRIOR TO WHEN THE ALLEGED ISSUE BEGAN. THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE TREATMENT DUE TO THE ALLEGED ISSUE AND THERE IS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS' ACCURACY CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING A DUODENAL STENTING PROCEDURE WITHIN A PATIENT WITH STOMACH CANCER ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A SEVEN CENTIMETER LESION BETWEEN THE STOMACH AND DUODENUM. DURING THE PROCEDURE, THE STENT DEVICE WAS SUCCESSFULLY INSERTED INTO THE ENDOSCOPE WITHOUT RESISTANCE. DURING DEPLOYMENT, AS THE PHYSICIAN WITHDREW THE DEPLOYMENT HANDLE, THE HANDLE DETACHED. AS A RESULT, THE STENT WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A 22 X 90 MM WALLFLEX ENTERAL DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3020215

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR