BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 3031906 · Received April 3, 2013

    Report

    Report Number
    3008382007-2013-06877
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 19, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (4/29/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING. THE ALLEGED ISSUE WAS NOT OBSERVED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER READ INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HIS BLOOD GLUCOSE 4X DAILY AND MANAGES HIS DIABETES WITH INSULIN PUMP THERAPY. THE ALLEGED ISSUE BEGAN A COUPLE WEEKS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "339 MG/DL" WITH THE SUBJECT METER. THE PATIENT RECEIVED AN INCREASED DOSE OF INSULIN (AMOUNT NOT SPECIFIED) BASED ON THE ALLEGED RESULT. AFTER, THE PATIENT CLAIMS HE FELT LOW BLOOD GLUCOSE SYMPTOMS OF SWEATING, HOLLOW FEELING INSIDE AND WAS "LIKE IN A DREAM". THE PATIENT ATE 1 ½ GLUCOSE TABLETS AND DRANK ORANGE JUICE AS TREATMENT. ABOUT 30 MINUTES LATER, THE PATIENT RETESTED AND OBTAINED A BLOOD GLUCOSE RESULT OF "43 MG/DL". AT THAT TIME, THE PATIENT REPORTEDLY SUSPENDED HIS INSULIN PUMP FROM DELIVERING INSULIN. NO ADDITIONAL TREATMENT WAS SPECIFIED. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136110 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3380065

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R