BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2132667 · Received June 17, 2011

    Report

    Report Number
    2939301-2011-04952
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2 (09/23/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN 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. 510K # IS K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (07/29/2011) - DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THE METER AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. THE METER HAS BEEN RETURNED TO LIFESCAN BUT THE EVALUATION HAS NOT BEEN COMPLETED AT THIS TIME. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL TO THE PATIENT. THE PATIENT REPORTED THAT ON (B)(6) 2011 AT 8:00PM, WHILE AT THE HOSPITAL VISITING HIS SPOUSE, HE TESTED HIS BLOOD GLUCOSE AND OBTAINED AN ALLEGED HIGH READING OF "7.3 MMOL/L" WITH THE SUBJECT METER. THE PATIENT INFORMED THE CSR THAT HE TESTS 3X/DAY AND MANAGES HIS DIABETES WITH HUMALOG (SLIDING SCALE) AND LANTUS (SET DOSE) INSULIN. THE PATIENT REPORTED FEELING "WEAKNESS AND FATIGUE" JUST PRIOR TO OBTAINING THE ALLEGED INACCURATE RESULT AND CLAIMED HE "PASSED OUT" SOON AFTER TESTING WITH THE SUBJECT METER. THE PATIENT STATED HE WAS TAKEN TO THE EMERGENCY ROOM BY HOSPITAL STAFF AND WHEN TESTED WITH AN ER/HOSPITAL METER, HIS BLOOD GLUCOSE WAS "1.1 MMOL/L". THE PATIENT CLAIMED THE TWO TESTS WERE PERFORMED 5 MINUTES APART FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THE "7.3 AND 1.1 MMOL/L" GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 1.7MMOL/L. THE PATIENT INFORMED THE CSR THAT HE WAS TREATED WITH "AN INJECTION TO THE BELLY" AND PLACED ON AN "IV DRIP". THE PATIENT REPORTED HE WAS KEPT OVERNIGHT IN THE ER AND RELEASED THE FOLLOWING MORNING. THE PATIENT STATED HE WAS TOLD BY THE ER PHYSICIAN THAT HE "PASSED OUT" DUE TO A LOW BLOOD GLUCOSE. PRIOR TO THE OBTAINING THE ALLEGED INACCURATE RESULT, THE PATIENT REPORTED THAT HE HAD LAST TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER THAT EVENING PRIOR TO SUPPER (TIME UNKNOWN) AND OBTAINED A RESULT OF "9.3 MMOL/L". THE PATIENT INFORMED THE CSR THAT HIS USUAL READINGS ARE "LESS THAN 10.0 MMOL/L". THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT IN RESPONSE TO THAT READING. THE PATIENT STATED THAT HE "ONLY HAD A SANDWICH" AT LUNCH AND SUPPER AND THAT MAY HAVE CONTRIBUTED TO THE LOW BLOOD SUGAR. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER OR TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THIS PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER OBTAINING AN ALLEGED INACCURATE READING WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3127847

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R