BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1498105 · Received September 4, 2009

    Report

    Report Number
    2939301-2009-05547
    Event Type
    Malfunction
    Date Received
    September 4, 2009
    Date of Event
    August 24, 2009
    Report Date
    August 25, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THIS SENIOR MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE REPORTER/LAYPERSON (PT'S MOTHER) REGARDING HER (B) (6) 2009, COMPLAINT OF ERRATIC ONETOUCH ULTRALINK METER BLOOD GLUCOSE RESULTS. THE RESULTS ARE MG/DL. THE REPORTER CLARIFIED AND REPORTED THE FOLLOWING INFO. AT 8:00 P.M., (B) (6) 2009, THE PT TESTED BEFORE EATING HIS DAILY EVENING SNACK (POST DINNER). DOUBTING THE FIRST RESULT, 200, BECAUSE HE FELT FINE, THE PT RETESTED, RESULT 109. THE PT QUESTIONED THE VARIANCE AND TESTED THREE MORE TIMES. THE PT USED FIVE DIFFERENT FINGERSTICKS TO OBTAIN BLOOD AND WASHED HIS HANDS BEFORE EACH PUNCTURE. THE REMAINING THREE RESULTS WERE 191, 167, AND "AROUND 181 OR 187." THE PT BASED HIS PUMP BOLUS ON THE 167 RESULT AND ATE THE SNACK. AT MIDNIGHT BEFORE GOING TO BED, THE PT'S BLOOD GLUCOSE WAS 185. THE PT BASED HIS NIGHTTIME DOSE OF INSULIN FROM THE PUMP ON THE RESULT. THE REPORTER COULD NOT RECALL THE AMOUNT OF INSULIN TAKEN. TWENTY MINUTES LATER, THE PT RE-TESTED (HIS USUAL NIGHTTIME ROUTINE), RESULT 81. THE VARIANCE BETWEEN THE TWO RESULTS WAS GREATER THAN THE EXPECTED <=20%; HOWEVER, THE INSULIN BETWEEN THE TESTS WOULD AFFECT THE COMPARISON. ALTHOUGH THE PT HAD NO SYMPTOMS, AS A PRECAUTION HE TURNED OFF HIS PUMP FOR TWO HOURS AND DRANK ORANGE JUICE BEFORE GOING TO SLEEP. THE REPORTER HAD NO CONTROL SOLUTION TO TROUBLESHOOT WITH THE CCA. THE REPORTER INFORMED THIS SPECIALIST THAT SHE RAN CONTROL TESTS ON NEW STRIPS WITH THE SUBJECT METER AFTER RECEIVING THE SUPPLIES; PRODUCT WAS IN RANGE. THERE IS NO INDICATION THE PRODUCT CONTRIBUTED TO INJURY SINCE THE PT HAD NO SYMPTOMS OF EITHER HIGH OR LOW BLOOD GLUCOSE AND RECEIVED NO MEDICAL INTERVENTION. SINCE THE VARIANCE OF THE RESULTS 200, 109, 191, 167 AND EITHER 181 OR 187 PERFORMED WITHIN LESS THAN 20 MINUTES DO NOT MEET THE CRITERIA OF <=20% DUE TO THE 109, THE COMPLAINT IS CLASSIFIED. THE CCA REPLACED ALL PRODUCTS.

    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 17 YR