BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1832906 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07841
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 30, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 510K # K073231.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRALINK METER DOES NOT TURN ON. THE PATIENT'S DIABETES IS MANAGED WITH AN INSULIN PUMP. THE POWER ISSUE BEGAN ON (B)(6) 2010. WITHIN A FEW HOURS, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "HEADACHE, SICK TO STOMACH, AND NAUSEA." AT AN UNSPECIFIED TIME, THE PATIENT TESTED ON THE ONETOUCH ULTRA2 METER OBTAINING A "HI-RESULT ABOVE 600 MG/DL." HIS HEALTHCARE PROVIDER ADVISED THE PATIENT TO TAKE 6 EXTRA UNITS OF INSULIN ON (B)(6) 2010 AND 7 EXTRA UNITS THE NEXT DAY. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE. THERE IS NO EVIDENCE THAT THE PATIENT SUFFERED A SERIOUS INJURY DUE TO THE PRODUCT ISSUE. GIVEN THE SHORT TIME BETWEEN THE ONSET OF THE ALLEGED ISSUE AND THE ALLEGED SYMPTOMS AND TREATMENT SUGGESTIVE FOR HYPERGLYCEMIA, THE PATIENT LIKELY FELT SYMPTOMATIC PRIOR TO OR WHEN THE ISSUE BEGAN. THEREFORE THE METER DID NOT CONTRIBUTE TO THE PATIENT'S SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 2982962

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR