BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1770729 · Received July 27, 2010

    Report

    Report Number
    2939301-2010-05941
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) REGARDING A CODING ISSUE ON HER ONETOUCH ULTRA METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON JULY 16, 2010, BUT THE PATIENT DECLINED TO ANSWER ANY QUESTIONS. THIS CASE IS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON AN UNSPECIFIED TIME ON (B)(6) 2010. THE CCA DOCUMENTED THAT THE PATIENT MANAGES HER DIABETES INSULIN (REGIMENT SPECIFICS UNKNOWN). IT IS NOT KNOWN WHEN THE PATIENT HAD TESTED LAST AND WHAT READINGS SHE WAS OBTAINING FROM THE ALLEGED METER PRIOR TO WHEN THE ISSUE STARTED. THE CCA DOCUMENTED THAT THE PATIENT'S CALL BEGAN WITH A CODING ISSUE, BUT THE PATIENT WAS FEELING "SHAKY, NERVOUS, NAUSEOUS, DIZZY, AND CONFUSED" AND WAS WAITING FOR THE AMBULANCE TO ARRIVE WHEN SHE CONTACTED LFS. THE PATIENT STATED THAT HER SYMPTOMS OCCURRED A FEW MINUTES AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT INFORMED THE CCA THAT SHE HAD SURGERY (DATE AND TYPE OF PROCEDURE UNSPECIFIED) AND THAT SHE HAD USED THE LAST OF HER MEDICATION THAT MORNING (MEDICATION UNSPECIFIED). THE PATIENT CLAIMED THAT SHE WAS UNSURE IF HER SYMPTOMS WERE CAUSED BY HER LACK OF MEDICATION, LOW BLOOD SUGAR, OR HER RECENT SURGERY. THE CCA ALSO NOTED THAT THE PATIENT WAS OFTEN ERRATIC AND "SEEMING TO WANDER THE HOUSE IN A PANIC AND WAS OFF-TOPIC IN HER RESPONSES." THE PATIENT CLAIMED THAT SHE HAD EATEN FOOD AS TREATMENT, BUT IT HAD NOT HELPED IN RAISING HER BLOOD SUGAR. THE PATIENT STATED THAT SHE HAS INSULIN, BUT SHE WAS NOT COMFORTABLE USING IT. ALTHOUGH THE PATIENT MENTIONED THAT AN AMBULANCE WAS CALLED, IT IS UNKNOWN WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED. DURING THE TROUBLESHOOTING SESSION, THE CCA DOCUMENTED THAT THE PATIENT WAS TRAINED ON CHANGING THE CODE ON THE LFS METER AND THE ISSUE WAS RESOLVED. REPLACEMENT METER AND SUPPLIES WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN. THERE IS NO EVIDENCE THAT THE LFS METER PERFORMED IMPROPERLY SINCE THE ISSUE WAS RESOLVED WITH PATIENT TRAINING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R