BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2183430 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06586
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/12/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HIS ONE TOUCH ULTRALINK METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION. ON (B)(6) 2011 AT AN UNSPECIFIED TIME, THE PATIENT TESTED HIS BLOOD GLUCOSE ON THE ULTRALINK METER AND OBTAINED A 136 MG/DL AND TOOK HIS USUAL DOSAGE OF INSULIN FROM THE PUMP. HE DID NOT EXHIBIT ANY SYMPTOMS. HE LEFT THE HOUSE AND WHILE HE WAS DRIVING, HE NOTICED HE WAS SWERVING WHILE DRIVING, HE FELT DIZZY AND ALSO EXPERIENCED BLURRED VISION. DUE TO THE SYMPTOMS, HE PULLED OVER AND CONTACTED THE PARAMEDICS. WHEN THE PARAMEDICS ARRIVED THEY TESTED THE PATIENT ON THEIR METER AND OBTAINED A 19 MG/DL AND WAS TREATED WITH IV GLUCOSE. THE PATIENT ALSO MENTIONED THAT SAME DAY AT AN UNSPECIFIED TIME HE TESTED HIS BLOOD GLUCOSE ON HIS ULTRALINK METER AND OBTAINED A 339 MG/DL. HE DID NOT EXHIBIT ANY SYMPTOMS AND LESS THAN 30 MINUTES LATER HE TESTED ON ANOTHER METER AND OBTAINED A 319 MG/DL. READINGS ARE LESS THAN OR EQUAL TO 30 MG/DL (1.7 MMOL/L) OR 30%. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW HOW MUCH INSULIN WAS TAKEN VIA THE PUMP WITH THE RESULT OF 136 MG/DL. IT WOULD HAVE ALSO BEEN HELPFUL TO KNOW AFTER TREATMENT, WHAT THE PATIENT'S BLOOD GLUCOSE READING WAS AND WHETHER HE WAS TAKEN TO THE ER. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READINGS, HE TOOK IS INSULIN AND AT AN UNSPECIFIED TIME LATER HE DEVELOPED SYMPTOMS AND HAD TO BE TREATED BY PARAMEDICS FOR A BLOOD GLUCOSE OF 19 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3000862

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R