BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 652112 · Received November 23, 2005

    Report

    Report Number
    2939301-2005-05358
    Event Type
    Injury
    Date Received
    November 23, 2005
    Date of Event
    November 9, 2005
    Report Date
    November 22, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2005, THE LAY REPORTER, THE LAY PT'S FAMILY MEMBER CONTACTED LIFESCAN ALLEGING THAT THE PT'S ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. ABOUT TWO WEEKS EARLIER AT 12:25 PM, THE PT OBTAINED A RESULT OF 213 MG/DL ON THE REPORTED METER BEFORE LUNCH. HE TOOK 3 UNITS OF NOVORAPID INSULIN AS USUAL AND ATE LUNCH. THE FAMILY MEMBER DID NOT KNOW WHAT THE PT ATE FOR LUNCH. AT 3:30 PM, THE PT "HAD SWEATS, WAS THIRSTY, AND WANTED TO SLEEP". THE FAMILY MEMBER SAID THE PT ALSO HAD A THROAT INFECTION. THE PT TESTED WITH THE METER AND OBTAINED A RESULT OF 398 MG/DL. THE FAMILY MEMBER CALLED THE HOSP AT 3:30 PM BECAUSE SHE THOUGHT THE PT WAS HYPOGLYCEMIC, BASED ON HIS SYMPTOMS. SHE WAS ADVISED TO TEST THE PT FOR URINE KETONES. AT 4:00 PM, THE URINE KETONE TEST WAS NEGATIVE AND THE PT HAD NO FEVER. THE PT DID NOT TAKE HIS USUAL 4:00 PM DOSE OF 2 UNITS OF NOVORAPID INSULIN. AT 4:10 PM, THE FAMILY MEMBER CALLED THE DR BECAUSE THE PT WAS SWEATING AND SLEEPY. THE DR CAME TO SEE THE PT, TESTED THE PT WITH THE REPORTED METER, AND OBTAINED A RESULT OF 194 MG/DL. THE PT'S PULSE WAS LOW AT THIS TIME; THE SPECIFIC PULSE RATE WAS NOT PROVIDED. THE PT HAD A CARDIAC MEDICAL HISTORY; HIS SPECIFIC CARDIAC DIAGNOSIS WAS NOT PROVIDED. THE DR CALLED EMERGENCY SERVICES. AT 4:30 PM EMT ARRIVED, DID NOT IMMEDIATLEY TEST THE PT'S BLOOD GLUOCOSE, AND GAVE THE PT "3 SUGARS AND COCA COLA". A FEW MINUTES LATER, A RESULT OF 50 MG/DL WAS OBTAINED ON THE EMT METER. EMT'S TOOK THE PT TO THE HOSP; HIS TEMPERATURE WAS LOE ON ARRIVAL 33 DEGREE C). THE FAMILY MEMBER DID NOT RECALL IF THE PT'S BLOOD GLUCOSE WAS TESTED ON ARRIVAL AT THE HOSPITAL. AT 5:11 PM A RESULT OF 73 MG/DL WAS OBTAINED ON THE HOSP METER. THE PT WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS. THE FAMILY MEMBER DID NOT KNOW THE PT'S ADMISSION DIAGNOSIS. THE CUSTOMER SERVICE AGENT (CSA) DISCOVERED THAT THE TEST STRIPS WERE BEING STORED INCORRECTY AT A LOW TEMPERATURE IN THE CELLAR AND THE PT WAS NOT CLEANING THE PUNCTURE SITE CORRECTLY. INCORRECT TEST STRIP STORAGE AND IMPROPER CLEANING OF THE PUNCTURE SITE CAN CONTRIBUTE TO INACCURATE RESULTS. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE REPORTED METER READ INACCURATELY HIGH COMPARED TO THE EMT METER AND PT'S SYMPTOMS WHEN THE PT WAS HYPOGLYCEMIC. THE METER MAY HAVE READ INACCURATELY HIGH 3 TO 4 HOURS EARLIER WHEN THE PT TOOK INSULIN AFTER TESTING WITH THE METER, WHICH MAY HAVE CONTRIBUTED TO THE PT EXPERIENCING HYPOGLYCEMIA AND MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R