BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1163073 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02250
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON THE EVENT DATE, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRALINK METER WAS READING INACCURATELY. THE PT TESTS HIS BLOOD GLUCOSE 5-6 TIMES A DAY. HE UTILIZES AN INSULIN PUMP. IT IS NOT KNOWN WHAT TYPE(S) OF INSULIN THE PT IS TAKING. THE REPORTER INDICATED THAT THE METER HAD BEEN GIVING LOW READINGS SINCE 2008. THE REPORTER ALSO MENTIONED THAT IN 2008, AT 1:00PM, THE PT GOT A METER READING OF "73 MG/DL." IT IS NOT KNOWN IF THE PT WAS SYMPTOMATIC AT THE TIME OR WHAT ACTIONS HE TOOK IN RESPONSE TO GETTING THE METER READING. AT 4:20 PM THAT SAME DAY, THE PT RETESTED HIS BLOOD GLUCOSE AND GOT A RESULT OF "520 MG/DL." BASED ON THE METER READING, THE PT TOOK "21.5 UNITS" OF INSULIN. AT 5:10 PM THAT SAME DAY, THE PT RETESTED HIS BLOOD GLUCOSE AND GOT A RESULT OF "41 MG/DL." AGAIN, IT IS NOT KNOWN IF THE PT WAS SYMPTOMATIC AT THE TIME OR WHAT ACTIONS HE TOOK IN RESPONSE TO GETTING THE METER READING OF "41 MG/DL." A HALF HOUR LATER, THE REPORTER CLAIMED THAT THE PT "BECAME INCOHERENT" AND WAS "ALMOST UNCONSCIOUS." HE WAS ALSO DESCRIBED AS HAVING SLURRED SPEECH, FEELING FAINT, HAVING BUCKLING KNEES, AND WAS SWEATING. ANOTHER RESULT OF "44 MG/DL" WAS REPORTED BUT IT IS NOT KNOWN WHAT TIME READINGS WAS OBTAINED. THE REPORTER HAD ALSO TESTED THE PT ON A NON-LFS METER AND A RESULT OF "67 OR 64 MG/DL" WAS OBTAINED. THE REPORTER CALLED THE PARAMEDICS. WHEN THE PARAMEDICS ARRIVED AT AN UNSPECIFIED TIME BETWEEN 6:00-7:00 PM THAT SAME DAY, THEY TESTED THE PT'S BLOOD GLUCOSE USING AN EMT METER AND GOT A RESULT OF "31 MG/DL." THE PT WAS TREATED WITH ORAL GLUCOSE AND AN IV (UNKNOWN CONTENTS). THE REPORTER STATED THAT THE PT WAS HOSPITALIZED OVERNIGHT SINCE HIS BLOOD GLUCOSE WAS SO LOW. THE HOSPITAL ADVISED THE PT TO ADMINISTER HIS OWN INSULIN MANUALLY AND NOT TO USE HIS PUMP UNTIL HIS METER WAS FIXED OR REPLACED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: WHAT TIMES THE RESULTS OF "44 AND 67 OR 64 MG/DL" WERE OBTAINED, AND WHAT ACTIONS THE PT OR REPORTER TOOK IN RESPONSE TO GETTING THE RELATIVELY LOW BLOOD GLUCOSE READINGS. THE PT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. THE REPORTER DID NOT HAVE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON AN INACCURATE HIGH METER READING. THE PT REPORTEDLY WAS ALSO HOSPITALIZED AND RECEIVED ORAL GLUCOSE AND IV TREATMENT AFTER THE ALLEGED ISSUE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2829918

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R