BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SS ENHANCED METER

    MDR report key: 732666 · Received July 5, 2006

    Report

    Report Number
    2939301-2006-00913
    Event Type
    Injury
    Date Received
    July 5, 2006
    Report Date
    June 24, 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 EVALUATION, 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, LIFESCA WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2006 THE LAY USER/REPORTER (PT'S WIFE) CONTACTED LIFESCAN ALLEGING THAT THE ONE TOUCH SURESTEP WAS READING INACCURATELY LOW BECAUSE THE METER WAS INCORRECTLY SET TO "MMOL/L." THE MED AFFAIRS SPEC. SPOKE WITH THE PT 3 DAYS LATER TO OBTAIN/VERIFY THE FOLLOWING INFO. APPROX 3 MONTHS AGO, THE PT REPLACED THE METER'S BATTERY AND DID NOT MAKE ANY ADJUSTMENTS TO THE METER SETTINGS. AFTER BATTERY WAS REPLACED, THE PT WAS GETTING READINGS SUCH AS "118 AND 130" (PT IGNORED THE DECIMAL POINTS) ON HIS METER AND FELT THAT HIS BLOOD GLUCOSE LEVELS WERE DOING WELL; HOWEVER, HE FELT DISORIENTED, AND HAD A DRY MOUTH, VOMITTING, NAUSEA, DIZZINESS, LACK OF ENERGY, AND NEUROPATHY IN LEGS. SINCE HIS METER READINGS WERE "NORMAL" THE PT TOOK LESS HUMALOG INSULIN THAN USUAL; HOWEVER, HE KEPT HIS USUAL LANTUS DOSAGES. FOR THE PAST 3 MONTHS, THE PT HAD VERY LITTLE ENERGY AND THOUGHT THAT HE "WAS GOING TO DIE." CONCERNED WITH HIS SYMPTOMS, HE WENT AND SAW A NEW DR 2 DAYS BEFOR THE CALL WHO RAN SOME LAB TESTS, GAVE HIM AN INSULIN SHOT AND A NEW "ASCENSIA" BLOOD GLUCOSE METER. THAT NIGHT THE PT WENT HOME AND TESTED ON HIS NEW METER AND GOT A READING OF "352 MG/DL". HE WAS "SURPRISED" THAT HIS BLOOD GLUCOSE LEVELS WERE HIGH AND THIS WAS WHEN THE PATIENT REALIZED THAT SOMETHING WAS WRONG WITH THE REPORTED METER. NEXT DAY, THE PATIENT CALLED HIS DR TO OBTAIN HIS LAB RESULTS AND FOUND THAT HIS BLOOD GLUCOSE WAS "400 MG/DL" AND HIS HBA1C WAS "6.0". THE CUSTOMER CARE ADVOCATE (CCA) WALKED THE REPORTER THROUGH RESETTING THE METER'S UNIT OF MEASURE SETTING. IN THE METER'S MEMORY, THE PT'S MOST RECENT READINGS WERE "185, 348, 335, 211, 333 MG/DL" THAT WERE OBTAINED OVER A FEW DAYS PERIOD. THE CCA VERIFIED THAT THE CORRECT TESTING TECHNIQUE WAS USED AND THE PUNCTURES SITE WAS PROPERLY CLEANED AT THE TIME OF TESTING; HOWEVER, THE METER WAS INCORRECTLY CLEANED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT OBTAINED "MMOL/L" METER READINGS THAT HE RECEIVED TO BE LOW WHILE EXPERIENCING SYMPTOMS. IN RESPONSE TO THE METER READINGS, THE PT WITHHELD HIS INSULIN DOSAGES AND DEVELOPED HYPERGLYCEMIA.THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SS ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2627352

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R