BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1831463 · Received September 10, 2010

    Report

    Report Number
    2939301-2010-07775
    Event Type
    Injury
    Date Received
    September 10, 2010
    Report Date
    August 31, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: K061118.

    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 ULTRAMINI METER DOES NOT TURN ON. THE PATIENT'S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. THE POWER ISSUE BEGAN 3 MONTHS PRIOR TO CONTACTING LFS. AS A RESULT OF THE PRODUCT ISSUE, THE PATIENT DECREASED HER INSULIN INTAKE OF 70/30 AND R. ON (B)(6), 2010, THE PATIENT CLAIMED SHE WENT INTO A DIABETIC COMA AND WAS TAKEN BY AMBULANCE TO THE HOSPITAL. REPORTEDLY, THE PATIENT RECEIVED "RESPIRATORY THERAPY" IN THE EMERGENCY ROOM AS SHE WAS NOT BREATHING. 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 REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE WENT INTO A DIABETIC COMA 3 MONTHS AFTER THE POWER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3001587

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R