BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1398285 · Received May 29, 2009

    Report

    Report Number
    2939301-2009-03204
    Event Type
    Injury
    Date Received
    May 29, 2009
    Report Date
    May 22, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    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.

    Description of Event or Problem · 1

    THE LAY USER/PT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON MAY 22, 2009, ALLEGING THAT HER ONE TOUCH ULTRA METER WAS READING INACCURATELY AND REPORTEDLY DEVELOPED SYMPTOMS AFTERWARDS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PT ON MAY 28, 2009 TO OBTAIN/VERIFY THE FOLLOWING INFORMATION: THE PT FIRST NOTICED THE ALLEGED INACCURACY ISSUE ABOUT 3 WEEKS PRIOR TO CONTACTING LIFESCAN, WHEN SHE COMPARED HER BLOOD GLUCOSE RESULTS FROM THE SUBJECT METER TO HER SISTER'S METER. THE RESULT ON THE SUBJECT METER WAS ABOUT 60 POINTS HIGHER: RESULTS WERE NOT SPECIFIED. ON ANOTHER OCCASION, THE PT TESTED ON HER METER WHILE FEELING HOT AND SWEATY, WHICH SHE BELIEVED WAS DUE TO LOW BLOOD GLUCOSE. SHE TESTED ON HER METER AND GOT "120 MG/DL." AS A RESULT OF THE METER READING, SHE DID NOT ADMINISTER ANY SELF-TREATMENT. THE PT RETESTED 30 MINS LATER, AND THE RESULT WAS "247 MG/DL," WHICH SHE FELT WAS INACCURATE HIGH. SHE CLAIMED THAT HER SYMPTOMS WENT AWAY AT AN UNSPECIFIED TIME WITH NO TREATMENT. THE PT ALSO REPORTED ANOTHER INCIDENT WHERE SHE WAS FEELING HOT, SWEATY, AND ALMOST PASSING OUT. SHE TESTED ON HER METER AND IT WAS "94 MG/DL." THE PT DID NOT EAT OR DRINK ANYTHING AFTER THE TEST. HER GIRLFRIENDS WERE CONCERNED, SO THEY TOOK HER TO THE DOCTOR. WHEN SHE ARRIVE AT THE DOCTOR'S OFFICE, HER BLOOD GLUCOSE WAS "93 MG/DL" ON THE DOCTOR'S METER. THE PT DID NOT RECEIVE ANY DIABETES RELATED TREATMENT DURING THE VISIT. SHE CLAIMED THAT HER SYMPTOMS WENT AWAY 2-3 HOURS LATER. SHE WAS ALSO CONCERNED WITH TEST RESULTS THAT SHE GOT THERE WERE OBTAINED BACK-TO-BACK. THE PT OBTAINED RESULTS OF "124, 161, 249 MG/DL" WITHIN A 10 MIN TIME PERIOD. ACCORDING TO THE PT, THE PT DID NOT MAKE ANY CHANGES TO HER MEDICATIONS (GLIPIZIDE AND METFORMIN) AS RESULT OF HER METER READINGS; HOWEVER, SHE STATED THAT SHE HAD ADJUSTED HER DIET (I.E. EAT LESS) AS A RESULT OF A HIGH METER READING, SUCH AS "247 MG/DL," AND THEN FELT "LOW." THE PT WAS UNABLE TO REPORT IF SHE RECEIVED ANY TREATMENT AT THIS TIME. BLOOD GLUCOSE RESULTS OF "124, 161, AND 249 MG/DL" WERE OBTAINED ON THE SUBJECT METER WITHIN LESS THAN 10 MINS TIME PERIOD ON AN UNSPECIFIED DATE/TIME. AS A RESULT OF THE ALLEGED INACCURACY ISSUE, THE PT CONSUMED LESS FOOT/DRINK ON THE EVENT DAY AT 9AM. THIS COMPLAINT IS BEING REPORTED, BECAUSE THE PT ALLEGEDLY BECAME HYPOGLYCEMIC AFTER EATING LESS FOOD AS A RESULT OF OBTAINING A HIGH METER READING. IT IS NOT KNOWN IF THE PT RECEIVED ANY FORM OF MEDICAL INTERVENTION. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2881168

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening