BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1842956 · Received September 23, 2010

    Report

    Report Number
    2939301-2010-08313
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    September 17, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    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; 510(K)# IS K073231.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT10/28/2010. 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.

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "73 MG/DL" WITH A LIFESCAN METER AND "42 MG/DL" ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY, GREATER THAN 1 MG/DL (0.056 MMOL/L) PER MINUTE AND GREATER THAN 20 MG/DL (1.11 MMOL/L) OR 20%. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO THE MANUFACTURER A BIPAP AUTO DEVICE PRESSURE DECREASED WHILE IN USE ON A PT. THE PT WAS TAKEN TO THE HOSPITAL FOR SHORTNESS OF BREATH AND ADMITTED TO THE HOSPITAL. WHILE THE PT WAS USING THE BIPAP IN THE HOSPITAL THE DEVICE ALLEGEDLY STOPPED CYCLING PROPERLY, THE PRESSURE PROVIDED TO THE PT DECREASED, AND THE PT ARRESTED. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED AND THE PT RECOVERED AND WAS PLACED ON ANOTHER DEVICE. THE PT WAS DISCHARGED TWO DAYS LATER AND IS NOW ON CONTINUOUS OXYGEN THERAPY. THE DEVICE WAS RETURNED AND EVALUATED BY THE MANUFACTURER. THE CUSTOMER'S ALLEGED COMPLAINT WAS NOT CONFIRMED BY THE MANUFACTURER. THE MANUFACTURER CONFIRMED THE PRESSURE OUTPUT OF THE DEVICE DID SLIGHTLY FLUCTUATE BUT THE OBSERVED FLUCTUATION WAS WITHIN DESIGN SPECIFICATION. THE ERROR LOG OF THE BIPAP WAS REVIEWED AND FOUND TO CONTAIN NO LOGGED ERROR CODES. THE DEVICE PASSED ALL STANDARD FUNCTIONAL AND OPERATIONAL TESTING DURING THE INVESTIGATION. THE PT HAS A MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND OBSTRUCTIVE SLEEP APNEA. THE DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THE PT GETS ANXIOUS AND IS ADMITTED TO THE HOSPITAL WITH BREATHING COMPLICATIONS FREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3038039

    Patients

    Seq Age Sex Outcome Treatment
    1