BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 4201412 · Received October 27, 2014

    Report

    Report Number
    2939301-2014-28722
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    October 17, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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 THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (12/26/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 12/15/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/15/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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

    THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(6) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH IN COMPARISON TO HER FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND INFORMATION OBTAINED IN FOLLOW-UP QUESTIONS FROM MEDICAL SURVEILLANCE (MS). THE PATIENT REPORTED THAT ON (B)(6) 2014, AT 08:10PM, SHE OBTAINED A RESULT OF ¿OVER 500MG/DL¿, WHEN TESTING WITH THE SUBJECT METER. THE PATIENT CLAIMED THAT SHE ALSO RECEIVED RESULTS OF ¿500MG/DL¿ ON (B)(6) 2014. THE PATIENT DETAILED THAT SHE MANAGES HER DIABETES USING AN INSULIN PUMP AND REPORTED THAT SHE ADMINISTERED DOSES OF HER MEDICATION BASED ON THE ALLEGEDLY INACCURATE HIGH BLOOD GLUCOSE READINGS. THE PATIENT CLAIMED THAT ¿APPROXIMATELY WITHIN AN HOUR¿ AFTER OBTAINING THE INACCURATE RESULTS, SHE DEVELOPED SYMPTOMS OF FEELING ¿DISORIENTATED, SWEATY, SHAKY AND HAD BLURRY VISION¿, WHICH SHE CONFIRMED SHE ASSOCIATED WITH LOW BLOOD GLUCOSE. THE PATIENT REPORTED THAT SHE TREATED HER SYMPTOMS WITH FOOD OR DRINK ON (B)(6) 2014 AT AN UNSPECIFIED TIME, AND AGAIN ON (B)(6) 2014, AT 07:14PM. DURING TROUBLESHOOTING, THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THAT THE TEST STRIPS HAD NOT BEEN OPEN LONGER THAN THE DISCARD DATE, EXPIRED, OR STORED IMPROPERLY. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A CONTROL SOLUTION TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT THEY TOOK INCORRECT ACTION BASED ON ALLEGEDLY INACCURATE METER READINGS AND REPORTED DEVELOPING SYMPTOMS SUGGESTIVE OF A SEVERE HYPOGLYCEMIC EXCURSION AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684049 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3605027

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R