BEUDAMED
    FDA Adverse Event Death Summary report: N

    OT ULTRA METER

    MDR report key: 1924704 · Received December 14, 2010

    Report

    Report Number
    2939301-2010-10713
    Event Type
    Death
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/REPORTER, THE PATIENT'S WIFE, CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH ULTRA METER WAS GIVING INACCURATELY HIGH READINGS. ON (B)(6) 2010, THE PATIENT'S WIFE CALLED TO REPORT THE PATIENT'S DEATH. ON THE FOLLOWING DAY, THE SR. MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE WIFE TO OBTAIN AND VERIFY INFORMATION DETAILED BELOW. THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAD BEEN OBTAINING INACCURATELY HIGH READINGS FOR THE PAST THREE MONTHS SINCE RECEIVING A NEW BATCH OF TEST STRIPS FROM MAIL ORDER. ON (B)(6) 2010, THE PATIENT CALLED LFS TO REPORT OBTAINING RESULTS OF 227 MG/DL AND 386 MG/DL WITHIN 2 MINUTES. THIS COMPLAINT WAS CATEGORIZED AS AN IMPRECISION COMPLAINT. DURING TROUBLESHOOTING, CONTROL SOLUTION TESTING WAS PERFORMED AND PASSED, BUT CUSTOMER SERVICE DETERMINED THAT THE CALIBRATION CODE HAD BEEN SET INCORRECTLY. LFS SENT THE PATIENT COMPLIMENTARY TEST STRIPS. THE PATIENT'S WIFE STATED THAT ON THE EVENING OF (B)(6) 2010, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 229 MG/DL ON THE OT ULTRA METER. THE TEST STRIP LOT NUMBER REPORTED BY THE PATIENT'S WIFE WAS THE SAME AS ASSOCIATED WITH THE (B)(6) 2010 COMPLAINT, BUT IT IS NOT KNOWN WHETHER THE STRIPS USED TO PERFORM THIS TEST ON (B)(6) 2010 WERE FROM THE SAME VIAL AS THE ONES USED TO PERFORM THE TEST ON (B)(6) 2010. THE PATIENT'S WIFE REPORTED GIVING HIM TEN UNITS HUMALOG 70/30 INSULIN BASED ON HIS SLIDING SCALE. THE WIFE REPORTED THAT ON (B)(6) 2010 AT 7:30 AM, THE PATIENT EXPERIENCED SWEATING, SHAKING AND CONVULSIONS. THE WIFE REPORTED THAT SHE HELPED THE PATIENT CONSUME A PROTEIN BAR AND ORANGE JUICE. HIS BLOOD GLUCOSE WAS TESTED WITH THE OT ULTRA METER AND FOUND TO BE 89 MG/DL. THE WIFE CALLED 911 AND STATED THAT THE PARAMEDICS ARRIVED AT 8:00 AM AND TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL TO BE 40 MG/DL WITH A BAYER METER. THE WIFE REPORTED THAT THE PARAMEDICS TREATED THE PATIENT WITH GLUCOSE GEL AND TRANSPORTED HIM TO THE HOSPITAL, WHERE HE WAS DIAGNOSED WITH HYPOGLYCEMIA. THE WIFE REPORTED THAT THE PATIENT LATER BECAME COMATOSE AND WAS PLACED ON LIFE-SUPPORT FOR 10 DAYS. THE PATIENT PASSED AWAY ON (B)(6) 2010. LFS BECAME AWARE OF THE PATIENT'S DEATH ON (B)(6) 2010. THE PATIENT'S WIFE DID NOT HAVE ACCESS TO MEDICAL RECORDS OR A DEATH CERTIFICATE AT THE TIME OF LFS'S FOLLOW UP CALL TO HER. HOWEVER, SHE REPORTED THAT HE HAD MULTIPLE MEDICAL PROBLEMS INCLUDING PARKINSON'S DISEASE, DIABETES FOR THE PAST 20 YEARS, CHRONIC RENAL FAILURE, HIGH BLOOD PRESSURE, AND CORONARY HEART DISEASE WITH THREE PRIOR MYOCARDIAL INFARCTIONS AND BYPASS SURGERY. THE PATIENT HAD BEEN UNDERGOING DIALYSIS FOR TWO YEARS. TO DATE THE PATIENT'S WIFE HAS NOT AGREED TO RETURN THE METER AND TEST STRIPS TO LFS FOR TESTING. ALTHOUGH LFS HAS NOT HAD AN OPPORTUNITY TO PERFORM A PRODUCT INVESTIGATION ON THE PATIENT'S TEST STRIPS THIS COMPLAINT IS BEING REPORTED AS THE WIFE STATED THAT THE PATIENT BECAME HYPOGLYCEMIC AFTER BEING GIVEN INSULIN FOLLOWING A GLUCOSE RESULT ON A LFS METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2963970

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death