BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1841785 · Received September 22, 2010

    Report

    Report Number
    2939301-2010-08297
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    September 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON SEPTEMBER 3, 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRALINK METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2010; HOWEVER, THE PATIENT DOES NOT RECALL WHAT THE ALLEGED INACCURATE ERRATIC RESULTS ARE. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HIS DIABETES WITH INSULIN (ADMINISTERED VIA INSULIN PUMP); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED ISSUE. AT AN UNKNOWN TIME LATER, THE PATIENT CLAIMED HE DEVELOPED SYMPTOMS OF WEAKNESS, HUNGER, AND SWEATING AS A RESULT OF THE ALLEGED ISSUE. THE CSR NOTED THAT THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION OR TREATMENT AFTER THE REPORTED INACCURACY ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT DID NOT HAVE ALL OF HIS TESTING SUPPLIES. THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, HE WAS CLEANING THE PUNCTURE AREA PROPERLY, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL), AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening