BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 4133979 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26079
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    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
    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 IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (10/20/2014), THE PATIENT¿S METER HAS BEEN RETURNED ON 10/7/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/13/2014 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) ALLEGING THAT HIS ONETOUCH ULTRALINK METER WAS READING INACCURATELY COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT INDICATED THAT HE FIRST NOTICED THE METER WAS READING INACCURATELY ON (B)(6) 2014. THE CCA ORIGINALLY NOTED THAT THE PATIENT OBTAINED AN ALLEGED INACCURATE RESULT OF ¿168 MG/DL¿ COMPARED TO ¿200MG/DL¿ ON ANOTHER METER. HOWEVER, DURING THE FOLLOW-UP CALL WITH THE MSS, THE PATIENT COULD NOT RECALL THESE RESULTS BUT ALLEGED THAT THE READINGS ON THE SUBJECT METER DIFFERED FROM HIS WIFE¿S METER BY ¿100-125 POINTS¿. THE REPORTER MANAGES HIS DIABETES WITH INSULIN PUMP THERAPY. HE ALLEGED, AS A RESULT OF THE INACCURATE RESULTS OBTAINED ON THE SUBJECT METER, HIS BLOOD SUGAR DROPPED BECAUSE ¿THE PUMP DELIVERED TOO MUCH INSULIN¿. THE PATIENT FURTHER ALLEGED THAT HE DEVELOPED SYMPTOMS OF ¿SHAKES¿ AND WAS ¿HYPOGLYCEMIC¿ AS A RESULT. THE PATIENT REPORTED SELF-TREATING WITH FOOD/DRINK. DURING TROUBLESHOOTING THE CCA ESTABLISHED THAT THE PATIENT¿S METER HAD BEEN SET TO THE CORRECT UNIT OF MEASURE AND SAMPLES HAD BEEN TAKEN FROM THE SAME APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE OBTAINED INACCURATE RESULTS ON THE SUBJECT METER, HIS PUMP DELIVERED TOO MUCH INSULIN AND HE REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616968 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3619837

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR