BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 5161053 · Received October 20, 2015

    Report

    Report Number
    2939301-2015-44941
    Event Type
    Injury
    Date Received
    October 20, 2015
    Date of Event
    October 16, 2015
    Report Date
    October 16, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1. THE RETAIN TEST STRIPS FAILED PERFORMANCE TESTING WITH BLOOD. 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

    FOLLOW-UP #2.THE RETAIN TEST STRIPS HAVE BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ALTHOUGH IT WAS PREVIOUSLY REPORTED THAT THE RETAIN TEST STRIPS FAILED PERFORMANCE TESTING WITH BLOOD, THE EVALUATION HAS CONCLUDED THAT THE RETAIN TEST STRIPS PASSED ALL 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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HER ONETOUCH ULTRALINK METER READ INACCURATELY LOW. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2015 AT 1:30PM THEN OCCURRED AGAIN AT 3:00PM. THE PATIENT STATED THAT SHE OBTAINED RESULTS OF "123, 127 AND 123 MG/DL" USING THE SUBJECT METER COMPARED TO FEELINGS/NORMAL RESULTS. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. THE PATIENT STATED THAT SHE TOOK HER USUAL DOSE OF 0.9 UNITS OF INSULIN MEDICATION (INCLUDING SLIDING SCALE) ON (B)(6) 2015 (TIME NOT PROVIDED) IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOMS OF "SHAKY AND NERVOUS" SHORTLY AFTER THE ALLEGED PRODUCT ISSUE BEGAN; HOWEVER SHE DENIED THAT SHE RECEIVED TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A WALK-THROUGH TEST AND THE TEST STRIPS HAD NOT EXPIRED, BEEN OPEN FOR LONGER THAN THE DISCARD DATE OR STORED IMPROPERLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED THE SYMPTOM OF "SHAKY" AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THIS SYMPTOM DOES MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691518 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3839687

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening