BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1051860 · Received May 21, 2008

    Report

    Report Number
    2939301-2008-00851
    Event Type
    Injury
    Date Received
    May 21, 2008
    Report Date
    April 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE IT/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

    IN 2008, THE LAY-USER/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA 2 METER HAD AN "ERROR 1" ISSUE. THE REPORTER INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THE SAME DAY, AT AN UNSPECIFIED TIME. THE PT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME DURING THE TIME OF CONCERN, THE PT DEVELOPED SYMPTOMS OF FEELING CLAMMY, SWEATY, AND DELUSIONAL. THE PT WAS REPORTEDLY ADMITTED TO A HOSPITAL ON THE SAME DAY OF THE REPORTED METER ISSUE BEGAN. HE WAS TREATED WITH IV FLUIDS (UNK CONTENTS). HIS BLOOD GLUCOSE WAS TESTED ON A DOCTOR'S/CLINIC'S METER AND RESULTS OF "112, 139, AND 170 MG/DL" WERE OBTAINED. HOWEVER, IT IS NOT KNOWN WHAT TIMES THE RESULTS WERE OBTAINED. IT IS ALSO UNK IF THE PT WAS SYMPTOMATIC AT THE TIME THE TESTS WERE PERFORMED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: WHAT TIMES THE BLOOD GLUCOSE RESULTS WERE OBTAINED, WHY THE PT WAS HOSPITALIZED, WHAT HER DIAGNOSIS WAS, AND WHY SHE RECEIVED IV FLUID TREATMENT. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED, HER TESTING FREQUENCY, AND IF THE PT MADE ANY CHANGES TO HER DIABETES MGMT REGIMENS AS A RESULT OF THE ALLEGED ISSUE. THE ALLEGED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE REPORTER CLAIMED THAT THE PT DEVELOPED SYMPTOMS THAT CAN BE ATTRIBUTED TO SEVERE HYPOGLYCEMIA DURING THE TIME THE ALLEGED METER ISSUE BEGAN. IT IS NOT CLEAR WHAT DURATION OF TIME THE PT WAS UNABLE TO TEST OR WHAT ACTIONS HE TOOK BEFORE DEVELOPING THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2701606

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R