BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2172121 · Received July 22, 2011

    Report

    Report Number
    2939301-2011-06090
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    July 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE LOW ISSUE WITH HER ONE TOUCH ULTRALINK METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE REPORTER STATED THAT THE ALLEGED ISSUE STARTED ON (B)(6) 2011 AT 10:30 AM AT THE DOCTOR'S OFFICE. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "153 MG/DL" WITH THE SUBJECT METER AND "211 MG/DL" ON THE DOCTOR'S METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT COULD NOT RECALL EARLIER READINGS OBTAINED, BUT STATED "THEY WERE ALL INACCURATE LOW ANYWAY". SHE CLAIMED THAT THE DOCTOR GAVE HER AN A1C RESULT OF "8%", WHICH SHE STATED WAS THE "HIGHEST IT'S EVER BEEN", AND A NEW METER TO USE, WHICH REPORTEDLY GAVE HER ACCURATE RESULTS. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH THE INSULIN PUMP AND DUE TO THE ALLEGED ISSUE WITH THE SUBJECT METER, DENIED MAKING ANY CHANGES AND CONTINUED ADMINISTERING INSULIN AS USUAL BASED ON THE METER'S RESULTS. SHE CLAIMED THAT ON AN UNSPECIFIED DAY, A "FEW MONTHS EARLIER", SHE HAD AN "ACETONE TASTE" IN HER MOUTH AND A CONSTANT HEADACHE, WHICH SHE ASSOCIATED TO HIGH BLOOD GLUCOSE LEVELS. THE PATIENT DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS, OTHER THAN FOLLOWING HER USUAL INSULIN ROUTINE. DURING THE INITIAL CALL WITH LFS CUSTOMER SERVICE, THE PATIENT VERIFIED THAT SHE USED AN ADEQUATE SAMPLE SITE AND THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. LIFESCAN RECEIVED THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATIONS ON (B)(6) 2011, RESPECTIVELY. THE ALLEGED ISSUES WERE NOT CONFIRMED DURING INVESTIGATION WITH THE RETURNED METER AND RETURNED TEST STRIPS; HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO AN UNREPORTED ISSUE FOUND WITH THE RETURNED TEST STIRPS. THE RETURNED TEST STRIPS FAILED CONTROL SOLUTION TESTING (THE RESULTS READ ABOVE THE EXPECTED RANGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3077482

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR