BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1747293 · Received July 6, 2010

    Report

    Report Number
    2939301-2010-05324
    Event Type
    Injury
    Date Received
    July 6, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 17, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 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

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.510(K) # IS K062195.

    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

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    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/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRA METER IS GIVING INACCURATE HIGH READING OF 97 MG/DL COMPARED TO FEELING/ NORMAL RESULTS. THE PATIENT DIABETES IS NOT MANAGED WITH ANY MEDICATION BUT WITH DIET AND EXERCISE. THE INACCURATE HIGH ISSUE BEGAN APPROXIMATELY 2 MONTHS AGO PRIOR TO CONTACTING LFS. ON (B)(6) 2010 AT 5:10 PM, THE PATIENT DEVELOPED SYMPTOMS DESCRIBED AS "DIZZY LIKE SHE MAY PASS OUT, CONFUSIONS, AND SWEATY." THE PATIENT MANAGED HER DIABETES AS USUAL ON THE DAY OF CONCERN. THERE WAS ALLEGATION OF TREATMENT FOR SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA AS A RESULT OF THE PRODUCT ISSUE. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT ON (B)(6) 2010. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THERE WAS NO CONTROL SOLUTION TO PERFORM A QUALITY TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA AFTER THE PRODUCT ISSUE BEGAN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT WHEN A MAGNET WAS PLACED ON THIS IMPLANTED PACEMAKER, THE MAGNET RATE WAS 60 BPM. THE HEART RATE BEFORE THE MAGNET WAS APPLIED WAS 80 BPM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A HEALTH CARE PROFESSIONAL CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES FOR TECHNICAL ADVICE ON THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3003168

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening