BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SS ENHANCED METER

    MDR report key: 777066 · Received November 1, 2006

    Report

    Report Number
    2939301-2006-01527
    Event Type
    Injury
    Date Received
    November 1, 2006
    Date of Event
    October 18, 2006
    Report Date
    October 21, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    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 10/21/06 THE LAY USER/REPORTER (PT'S WIFE) CONTACTED LIFESCAN ALLEGING THAT THE PT'S ONE TOUCH SURESTEP WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS/NORMAL READINGS. THE MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT'S WIFE ON 10/27/06 TO OBTAIN/VERIFY THE FOLLOWING INFO. ON 10/18/06 AROUND 10PM, THE PT OBTAINED A "203 MG/DL" ON HIS METER, WITH NO SYMPTOMS, AND THEN TOOK 46 UNITS OF LANTUS BASED ONA SLIDING SCALE. WITHIN 15-20 MINUTES AFTER TAKING THE LANTUS, THE PT DEVELOPED SYMPTOMS OF PALPITATIONS OF HEART AND SWEATING AND HIS WIFE CALLED THE EMERGENCY SERVICES (EMS). THE PT ALSO TAKES HUMALOG FROM AN INSULIN PEN. WHEN THE MAS ASKED THE PT'S WIFE IF IT WAS POSSIBLE THAT THE PT TOOK HUMALOG AFTER OBTAINING THE "203 MG/DL" METER READING, SHE WAS UNABLE TO CONFIRM, SINCE SHE WAS NOT THERE WITH THE PT WHEN HE TOOK HIS INSULIN. WHILE WATING FOR THE EMS TO ARRIVE, THE PT HAD A SODA AND CANDY BARS. APPROX 20 MINUTES LATER, THE EMS TESTED THE PT ON THEIR METER AND GOT A "21 MG/DL." SINCE HE ALREADY HAD THE SODA AND CANDY BARS, THE PT WAS NOT GIVEN ADD'L TREATMENT BY THE EMS; HOWEVER, EMS STAYED FOR 45 MINUTES TO 1 HOUR TO MONITOR HIS BLOOD GLUCOSE LEVELS. THE EMS LEFT THE PT WHEN HIS BLOOD GLUCOSE INCREASED TO "60 MG/DL." THE CUSTOMER CARE VERIFIED THAT THE METER WAS CORRECTLY SET TO "MG/DL," AN APPROVED SAMPLE SOURCE (FINGER) WAS USED, AND THE CORRECT TESTING/CLEANING TECHNIQUES WERE USED. THE PT DID NOT HAVE CONTROL SOLUTION TO CHECK THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT BECAME HYPOGLYCEMIC ABOUT 15-20 MINUTES AFTER TAKING HIS INSULIN ON HIS METER READING. LIFESCAN REPLACED THE METER, TEST STRIPS, AND CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SS ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2644209

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R