BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1515798 · Received October 23, 2009

    Report

    Report Number
    2939301-2009-06543
    Event Type
    Injury
    Date Received
    October 23, 2009
    Report Date
    October 7, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM, AND INFORM THE FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2009, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRAMINI METER WAS GIVING THE ERROR 5 AND ERROR 2 MESSAGES. ONE WEEK LATER, THIS MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PT TO CLARIFY INFO OBTAINED DURING THE INITIAL PHONE CALL. THE PT TESTS HER BLOOD GLUCOSE 4 TO 6 TIMES PER DAY AND MANAGES HER DIABETES WITH LANTUS AND APIDRA INSULIN. THE PT TAKES APIDRA INSULIN BASED ON SLIDING SCALE PER THE LFS METER READINGS. ON ABOUT 3 OR 4 WEEKS PRIOR, THE PT REPORTEDLY COULD NOT OBTAIN HER BLOOD GLUCOSE READING ON THE SUBJECT METER DUE TO THE ERROR 5 AND ERROR 2 MESSAGE. ON THAT DAY, SHE WAS FEELING "LOW BLOOD GLUCOSE" SYMPTOMS AND WENT TO THE ER. THE PT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF "20 MG/DL" ON THE HOSPITAL METER. SHE WAS ADMITTED INTO THE HOSPITAL FOR 2 TO 4 DAYS AND WAS ALLEGEDLY TREATED FOR LOW BLOOD SUGAR. THE PT FELT THAT HAD SHE BEEN ABLE TO OBTAIN HER BLOOD GLUCOSE READINGS THAT DAY, SHE MAY HAVE BEEN ABLE TO PREVENT THE ALLEGED HYPOGLYCEMIC EPISODE ON THE DAY OF CONCERN. DURING THE CALLBACK, THE PT PROVIDED LIMITED INFO. IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT SPECIFIED SYMPTOMS THE PT HAD WHEN SHE OBTAINED A BLOOD GLUCOSE READING OF "20 MG/DL", HOW SHE MANAGED HER DIABETES ON THE DAY OF CONCERN, AND THE DOSE OF INSULIN SHE TOOK ON THE DAY OF CONCERN. THE PT WAS USING TWO DIFFERENT LOT# OF TEST STRIPS, 2891350 AND 2877244, WHILE SHE HAD THE PRODUCT ISSUES. THE PT DOES NOT RECALL WHICH LOT OF TEST STRIPS SHE WAS USING ON THE DAY OF CONCERN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TEST STRIPS WERE IN GOOD CONDITION, THE TESTING TECHNIQUE IS CORRECT, AND THE ERROR 2 MESSAGE OCCURRED WHEN THE TEST STRIP IS INSERTED INTO THE SUBJECT METER. THE ERROR 5 AND 2 MESSAGE COULD NOT BE RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE HAD LOW BLOOD GLUCOSE SYMPTOMS AND RECEIVED MEDICAL INTERVENTION AFTER THE PRODUCT ISSUES BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2877244

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R