BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1845025 · Received November 7, 2008

    Report

    Report Number
    2939301-2008-02988
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2008, A RPTR/LAYPERSON (GRANDMOTHER) ALLEGED THAT THE PT/LAYPERSON'S ONE TOUCH ULTRALINK METER RESULTS WERE INACCURATE ACCORDING TO THE HOSPITAL STAFF. THE CUSTOMER CARE ADVOCATE (CCA) REPLACED THE METER, TEST STRIPS, AND CONTROL SOLUTION. SINCE THIS SENIOR MEDICAL AFFAIRS SPECIALIST HAS BEEN UNABLE TO SPEAK WITH THE RPTR, A LETTER HAS BEEN SENT AND THE COMPLAINT IS CLASSIFIED BASED UPON THE FOLLOWING INFO THE RPTR GAVE TO THE CCA. RESULTS ARE IN MG/DL, THE CORRECT UNIT OF MEASURE. THE PT BEGAN THROWING UP EITHER THE NIGHT OF (B)(6) 2008, OR EARLY THE NEXT MORNING, (B)(6), WHILE STAYING WITH A FRIEND AND BEFORE TESTING. THE RPTR DROVE THE PT TO THE RPTR'S HOME WHERE SHE CONTINUED TO THROW UP AND LATER DISPLAYED LABORED BREATHING. REPORTEDLY, NO ADJUSTMENTS WERE MADE TO HER INSULIN PUMP DURING THIS TIME. THE PT DRANK WATER AND CONTINUED TO TEST. RESULTS OBTAINED WERE THE FOLLOWING: LOW, 8:07 AM; 137 AFTER THE LOW; THEN FORTY-FIVE MINUTES LATER 90 AND 99. THE RPTR STATED, "BECAUSE THE RESULTS DIDN'T GO UP, WE DIDN'T RUSH GETTING HER TO THE HOSPITAL." AROUND 10:00 AM, WHILE THE RPTR AND PT'S MOTHER DROVE THE PT TO THE ER, SHE OBTAINED "HI" (>600) ON HER METER. AT THE ER, THE PT'S BLOOD GLUCOSE AT 11:00 WAS "800". THE PT WAS TREATED WITH IV FLUIDS, AND AN INSULIN DRIP EITHER IN THE ER OR AFTER BEING MEDEVACED TO (B)(6) FOR INSURANCE PURPOSES. WHILE HOSPITALIZED, THE PT'S RESULTS WERE COMPARED TO EITHER THE LAB OR HOSPITAL METER; ACCORDING TO THE RPTR, THESE COMPARISONS WERE ACCEPTABLE TO THE STAFF. PRESUMABLY, THE RPTR WAS REFERRING TO RESULTS NOTED IN THE METER'S MEMORY OF 234 AND 216 AT 3:08 AND 3:09 PM ON (B)(6), AND 241 AND 216 AT 7:00 PM ON (B)(6). THE PT'S TEST STRIPS WERE NOT AVAILABLE DURING THE RPTR'S CALL. THE RPTR ALSO WAS CONCERNED THAT THE METER'S MEMORY CONTAINED ONLY THREE RESULTS IN (B)(6), AND NONE UNTIL (B)(6). WHETHER THE PT POSSIBLY WAS NOT TESTING IS UNCLEAR. THE ALLEGED MEMORY ISSUE HAS BEEN REPORTED AS A MALFUNCTION. BECAUSE THE PT'S SYMPTOMS BEGAN BEFORE THE ALLEGED ISSUE AND BECAUSE THE RESULT OF HI WAS COMPARABLE TO THE ER METER OR LAB RESULT AND TREATMENT, THERE IS NO EVIDENCE THE PRODUCT CONTRIBUTED TO THE SERIOUS INJURY. SINCE THE REPORTED RESULTS OF "LOW" (LESS THAN 20 MG/DL) AND 137 MG/DL ARE GREATER THAN THE EXPECTED COMPARISON OF <=20%, THE COMPLAINT IS CLASSIFIED AS AN ACCURACY AND PRECISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR