BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC METER

    MDR report key: 1862274 · Received October 8, 2010

    Report

    Report Number
    2939301-2010-08954
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PT IS FEMALE. 510 (K) # ISK023948. 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

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2010 ALLEGING INACCURATE READINGS ON HER ONE TOUCH BASIC METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2010 AT 7:00AM THE PATIENT HAD OBTAINED A RESULT OF 11.6 MMOL/L ( 208 MG/DL) AND TOOK 40 UNITS OF HUMALOG BASED ON HER PHYSICIAN'S RECOMMENDATION. SHE DID NOT EAT ANY BREAKFAST AND WENT FOR A 2 HOURS WALK THROUGH THE FOREST. AT 11:00AM, PRIOR TO LUNCH SHE OBTAINED A 5.1 MMOL/L (91 MG/DL) AND AFTER EATING LUNCH SHE TOOK 40 UNITS OF HUMALOG BASED ON HER PHYSICIAN'S RECOMMENDATION. SHE CLAIMS SHE ALWAYS TAKES 40 UNITS OF HUMALOG INSULIN AFTER LUNCH. AT 4:00PM, SHE DEVELOPED SYMPTOMS OF FEELING GIDDINESS, "BLACK BEFORE HER EYES", SWEATING AND UNCONSCIOUS". HER HUSBAND FOUND HER UNCONSCIOUS; HOWEVER, HE DID NOT ATTEMPT TO TEST HER BLOOD GLUCOSE. THE PATIENT DOES NOT REMEMBER HOW SOON AFTER SHE REGAINED CONSCIOUSNESS AND SELF-TREATED HERSELF WITH (B)(6) AND ATE A (B)(6). SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. AT 5:15PM SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A 5.5 MMOL/L ( 99 MG/DL) AND DID NOT TAKE ANY ACTION AFTER OBTAINING THAT BLOOD GLUCOSE READING. AT 7:00PM THAT NIGHT SHE OBTAINED A 15.4 MMOL/L ( 277 MG/DL) TOOK 48 UNITS OF BASAL INSULIN AND 12 UNITS OF HUMALOG INSULIN. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE TEST STRIPS PASSED USING THE CONTROL SOLUTION. METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT SHE RECEIVED HIGH READINGS AND A COUPLE OF LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND HAD TO SELF-TREAT AFTER REGAINING CONSCIOUSNESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R