BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2183655 · Received July 29, 2011

    Report

    Report Number
    2939301-2011-06608
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 3, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO HIS NORMAL RESULT(S). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS FOUR TIMES A DAY AND MANAGES HIS DIABETES WITH NOVOLOG R (SLIDING SCALE, BASED ON HIS READING WITH THE SUBJECT METER) AND 500MG OF METFORMIN TWICE A DAY. THE PATIENT INDICATED HIS USUAL BLOOD GLUCOSE READINGS ARE BETWEEN "120-149MG/DL". THE PATIENT CLARIFIED THAT WHEN HIS BLOOD GLUCOSE IS BETWEEN "46-60MG/DL" HE WOULD EXPERIENCE SYMPTOMS OF SWEATING; HOWEVER, THE PATIENT DENIED EXHIBITING ANY SYMPTOMS WHEN HIS BLOOD GLUCOSE IS READING ABOVE HIS TYPICAL RANGE. THE PATIENT CORRECTED AND CLARIFIED THAT ON (B)(6) 2011 HE OBTAINED BLOOD GLUCOSE RESULTS OF "215, 376, AND 238MG/DL" WITH THE SUBJECT METER; HOWEVER, THE TIME THE PATIENT OBTAINED THE READINGS ARE UNKNOWN. ACCORDING TO THE PATIENT HE ADMINISTERED 3 UNITS OF NOVOLOG R INSULIN AT LUNCH TIME AND 8 UNITS OF NOVOLOG R INSULIN AT DINNER TIME (THE PATIENT'S BLOOD GLUCOSE RESULTS PRIOR TO ADMINISTERING INSULIN ARE NOT KNOWN). THE PATIENT CLARIFIED THAT HIS WIFE HAD A DOCTOR'S OFFICE VISIT (AT THE HOSPITAL) SCHEDULED AT APPROXIMATELY 7PM THAT EVENING (AFTER DINNER TIME) AND WHILE DRIVING HIS WIFE TO HER APPOINTMENT, THE PATIENT INDICATED HE BEGAN TO FEEL SWEATY. IN RESPONSE TO HIS SYMPTOM, THE PATIENT INDICATED HE WENT DOWN TO THE EMERGENCY ROOM (ER). THE PATIENT INDICATED HIS BLOOD GLUCOSE WAS TESTED WITH THE ER'S METER AFTER HE ARRIVED, HOWEVER, HE DOES NOT RECALL THE RESULT HE OBTAINED. AFTER THE PATIENT WAS ADMINISTERED FOOD AS TREATMENT, THE PATIENT INDICATED HE OBTAINED A BLOOD GLUCOSE RESULT OF "396MG/DL" WITH THE SUBJECT METER AND "100MG/DL" WITH THE ER'S METER, PERFORMED NO MORE THAN FIVE MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT CORRECTED AND CLARIFIED HE WAS RELEASE FROM THE ER APPROXIMATELY THREE TO FOUR HOURS LATER; THE PATIENT'S BLOOD GLUCOSE RESULT PRIOR TO HIS RELEASE (WITH THE ER'S METER) IS NOT KNOWN. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT (MG/DL). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE RESULT WITH THE SUBJECT METER, DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY, AND WAS REPORTEDLY TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3110882

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R