BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1982506 · Received February 9, 2011

    Report

    Report Number
    2939301-2011-01241
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 02/25/2011. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    A 510 (K) # IS K021819. 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 REPORTER/ WIFE CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HER HUSBAND'S ONE TOUCH ULTRASMART METER. THE REPORTER MENTIONED THAT HE HAS HAD SEVERAL "HYPOGLYCEMIC" EVENTS IN (B)(6) 2010. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2010 AT 1:56 PM THE PATIENT OBTAINED A 67 MG/DL AND TOOK 14 UNITS OF ACTRAPID BASED ON A SLIDING SCALE . HE ATE SOMETHING AND HAD DEVELOPED SYMPTOMS, WHERE HE FELT SHAKY, SWEATY AND TIRED. HE TESTED HIS BLOOD GLUCOSE AND OBTAINED A 45 MG/DL AT 2:38PM. HIS WIFE GAVE HIM COLA, "GAPESUCKAR" AND APPLE JUICE . PATIENT FELT BETTER APPROXIMATELY 90 MINUTES LATER. ON (B)(6) 2010 AT 2:29 PM, HE TESTED HIS BLOOD GLUCOSE AND OBTAINED A 71 MG/DL AND-HE TOOK 14 UNITS OF ACTRAPID BASED ON A SLIDING SCALE . HE ATE SOMETHING THEN DEVELOPED SYMPTOMS OF FEELING SHAKY, SWEATY AND TIRED. HE TESTED HIS BLOOD GLUCOSE AT 2:55PM AND OBTAINED A 44 MG/DL. HIS WIFE GAVE HIM COLA, "GRAPESUCKAR" AND APPLE JUICE. PATIENT FELT BETTER APPROXIMATELY 90 MINUTES LATER. THE PATIENT NORMALLY TAKES A HALF PILL OF GLUCOPHAGE AFTER LUNCH BUT HE COULD NOT DURING THOSE 2 DAYS DUE TO THE HYPOGLYCEMIC EVENTS. ON THE EVENING OF (B)(6) 2011, HE COMPARED HIS METER TO THE HOSPITAL'S METER. THE LFS METER READ 134 MG/DL AND THE HOSPITAL DEVICE READ 85 MG/DL. A NORMAL READING FOR THE PATIENT IS BETWEEN 120-160 MG/DL. THE PHYSICIAN CHANGED THE PATIENT'S INSULIN TO NOVORAPID INSULIN BASED ON A SLIDING SCALE. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AND RAN OUT OF SUBJECT TEST STRIPS THAT HE WAS USING AT THE TIME OF THE EVENT. METER WAS REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE ALLEGED HIGH READINGS, THE PATIENT HAD TAKEN INSULIN BASED ON A SLIDING SCALE AND SHORTLY LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY HAD FELT BETTER AFTER BEING TREATED WITH FOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R