BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1861811 · Received October 8, 2010

    Report

    Report Number
    2939301-2010-08940
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K # IS K062195. 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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2010-04279 AND MFR. REPORT # 3005099803-2010-04280). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED DURING A TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE LEAKED FROM THE CONNECTION BETWEEN THE SYRINGE LUER AND THE GREY HANDLE, THUS PREVENTING SUFFICIENT SUCTION TO GET A SAMPLE. THE PROCEDURE WAS COMPLETED BY TAKING AN ADDITIONAL SAMPLE USING ANOTHER EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; NEEDLE BENT AND UNABLE TO RETRACT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2010 HE OBTAINED AN ALLEGED HIGH BLOOD GLUCOSE READING IN THE "140 TO 160 MG/DL" RANGE WITH THE SUBJECT METER. THE PATIENT STATED THAT HE GENERALLY TESTS IN THE "120 TO 130 MG/DL" RANGE AT THAT TIME. THE PATIENT INFORMED THE MSS THAT HE MANAGES HIS DIABETES BY TAKING BOTH HUMULIN N AND HUMULIN R BASED ON A SLIDING SCALE. THE PATIENT CONFIRMED LATER THAT EVENING, PRIOR TO GOING TO BED HE ADMINISTERED AN UNSPECIFIED AMOUNT OF HUMULIN N. THE PATIENT DID NOT RECALL THE NUMBER OF UNITS HE TOOK, BUT CONFIRMED HE MOST LIKELY TOOK AN INCREASED DOSE BASED ON THE ALLEGED HIGH RESULT HE OBTAINED EARLIER THAT DAY. THE PATIENT REPORTED THAT THE FOLLOWING MORNING (AT 6AM) HE WOKE UP FEELING WEAK, SWEATY AND HIS VISION WAS BLURRED. AT THE ONSET OF SYMPTOMS, THE PATIENT CLAIMED HE TESTED WITH ANOTHER DEVICE (ONE TOUCH BASIC) AND OBTAINED A RESULT THAT CORRELATED WITH HOW HE WAS FEELING. THE PATIENT CLAIMED HE THEN TREATED HIMSELF WITH FOOD AND DRINK AND FELT BETTER AFTERWARDS. LATER THAT DAY, THE PATIENT CLAIMED HE OBTAINED BLOOD GLUCOSE READINGS OF "135 MG/DL" WITH THE SUBJECT METER AND "116 MG/DL" ON HIS ONETOUCH BASIC METER, PERFORMED JUST A FEW MINUTES APART FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <=30%. 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 SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3046067

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R