BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC ENHANCED METER

    MDR report key: 2231770 · Received September 1, 2011

    Report

    Report Number
    2939301-2011-08505
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    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.THE 510(K) # IS K023948.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH BASIC METER WAS READING INACCURATELY HIGH. THE MSS MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE PATIENT ON (B)(4) 2011 SINCE THE REPORTER WAS NOT AVAILABLE AND OBTAINED ADDITIONAL INFORMATION. THE REPORTER CLAIMED THAT THE ALLEGED ISSUE OCCURRED ON AUGUST (B)(6) 2011, AT APPROXIMATELY 2 AM IN THE MORNING. THE REPORTER REPORTED BLOOD GLUCOSE RESULTS OF "208MG/DL" WITH THE SUBJECT METER AND "183MG/DL" ON ANOTHER METER (ACCU-CHECK COMPACT PLUS). IT IS NOT KNOWN WHAT THE TIME DIFFERENT WAS BETWEEN THE TWO TESTS. WHEN THE MSS SPOKE WITH THE PATIENT, HE COULD NOT RECALL TESTING AT THAT TIME AND STATED HE USUALLY TESTS TWICE PER DAY ONCE IN THE MORNING AND ONCE IN THE EVENING. IT WOULD HAVE BEEN HELPFUL TO UNDERSTAND WHAT PROMPTED THE TEST AT THAT PARTICULAR TIME. THE PATIENT INFORMED THE MSS THAT HE MANAGES HIS DIABETES WITH HUMALOG MIX 75/25 AND ADMINISTERS 15 UNITS IN THE MORNING AND 25 UNITS IN THE EVENING. THE PATIENT FURTHER STATED THAT HE TAKES 10 UNITS "LESS" THAN WHAT HIS DOCTOR HAS PRESCRIBED FOR EACH DOSE BECAUSE HE FELT THE PRESCRIBED AMOUNT WAS TOO MUCH. THE PATIENT STATED THAT HE HAS BEEN ADMINISTERING THE SAME AMOUNT OF INSULIN FOR A WHILE. PER THE CCA DOCUMENTATION, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF "DIZZINESS AND SWEATING" AT AN UNKNOWN TIME AFTER THE ALLEGED INACCURATE READINGS AND THAT HE SELF-TREATED WITH ORANGE JUICE AT AN UNSPECIFIED TIME. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE SAMPLE WAS TAKEN FROM AN APPROVED SAMPLE SITE. THE REPORTER DID NOT HAVE ANY OF THE PRODUCTS AVAILABLE AT THE TIME OF THE CALL TO CONFIRM PRODUCT INFORMATION SUCH AS NAME, LOT NUMBER, SERIAL NUMBER AND EXPIRATION DATES. THE MSS WAS NOT ABLE TO OBTAIN THIS INFORMATION DURING THE FOLLOW-UP DUE TO THE PATIENT STATING THAT HE NO LONGER HAS THE PRODUCTS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND SELF-TREATED AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R