BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 759446 · Received September 8, 2006

    Report

    Report Number
    2939301-2006-01210
    Event Type
    Injury
    Date Received
    September 8, 2006
    Date of Event
    August 1, 2006
    Report Date
    August 25, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2006, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT HIS ONE TOUCH ULTRA WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS/NORMAL READINGS. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PATIENT ON FIVE DAYS LATER, TO OBTAIN/VERIFY THE FOLLOWING INFORMATION. THE PATIENT TEST AT LEAST 6 TIMES A DAY AND TAKES GENERALLY 40 UNITS OF "HUMALOG" TWICE A DAY BUT ADJUSTS HIS INSULIN DOSAGES IF NECESSARY BASED ON A SLIDING SCALE. THE PATIENT WAS UNABLE TO PROVIDE HIS SLIDING SCALE REGIMEN, BUT STATED THAT IF HE GOT A READING AT 110-120'S MG/DL, HE WOULD NOT TAKE ANY INSULIN. IN THE LAST FEW DAYS PRIOR TO CONTACTING LIFESCAN ON ORIGINAL DATE, HE REPORTEDLY HAD SOME "SHAKES" AND OBTAINED METER READINGS THAT WERE NO HIGHER THAN "112 MG/DL". WHEN THE PATIENT FELT SHAKY, THE PATIENT HAD SOME "SUGAR" AND FELT BETTER, BUT DID NOT RETEST AFTER THE SYMPTOMS WERE GONE. HE FELT THAT HIS METER WAS READING INACCURATELY HIGH SINCE HE EXPECTED HIS BLOOD GLUCOSE TO BE "60-70MG/DL" WHEN HE IS SHAKY. FIFTEEN MINUTES PRIOR TO CONTACTING LIFESCAN, THE PATIENT GOT A "122 MG/DL" RESULT THAT WAS OBTAINED ON THE SAME DAY AT 6:29 AM. AT THE TIME OF THE TEST, THE PATIENT STATED THAT HE WAS FEELING SHAKY, HAD SOME JUICE, AND FELT BETTER. OVER THE PHONE WITH THE CUSTOMER CARE ADVOCATE (CCA), THE PATIENT RETESTED ON HIS METER AND GOT BACK-TO-BACK METER READINGS OF "276 AND 162 MG/DL." THE CCA VERIFIED THAT THE METER WAS CORRECTLY SET TO "MG/DL," AN APPROVED SAMPLE SOURCE (FINGER) WAS USED, AND THE CORRECT TESTING/CLEANING TECHNIQUES WERE USED. THE CCA DISCOVERED THAT SOME OF THE TEST STRIPS WERE STORED IMPROPERLY IN A PLASTIC BAG; HOWEVER, THE PATIENT INFORMED THE MAS THAT THE REPORTED "122, 276, AND 162 MG/DL" METER READINGS WERE OBTAINED FROM TEST STRIPS THAT WERE PROPERLY STORED IN A BOTTLE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED METER RESULTS DO NOT SEEM TO CORRELATE WITH THE PATIENT'S SYMPTOMS. IN ADDITION, THE REPORTED METER RESULTS EXCEED LIFESCAN'S PRECISION CRITERIA. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R