BEUDAMED
    FDA Adverse Event Death Summary report: N

    OT ULTRALINK METER

    MDR report key: 2282772 · Received October 7, 2011

    Report

    Report Number
    2939301-2011-09917
    Event Type
    Death
    Date Received
    October 7, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 28, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. CONTINUATION OF INCIDENT DESCRIPTION: THE READINGS OBTAINED ON (B)(6), 2011 CORRELATED WITH THE PATIENT'S SYMPTOMS. ADDITIONALLY, THE OTHER METER'S READINGS, ALTHOUGH LOWER THAN THE ULTRA'S READINGS, INDICATED THAT THE PATIENT'S BLOOD GLUCOSE WAS HIGH. THE METER WAS REQUESTED TO BE RETURNED TO LFS FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED TO INFORM FDA OF THE PATIENT'S DEATH. THE 510K#: K073231.

    Description of Event or Problem · 1

    ON (B)(6), 2011 THE HOMICIDE DETECTIVE/REPORTER CONTACTED LIFESCAN (LFS) TO REPORT A PATIENT USING THE ONETOUCH ULTRALINK METER HAD PASSED AWAY, AND THAT THE PATIENT'S MOTHER STATED THE REPORTED METER WAS "READING HIGH". THE PATIENT'S MOTHER IS HOSPITALIZED AND NOT AVAILABLE TO PROVIDE CLARIFICATION. ON (B)(6), 2011 THIS SR. MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE DETECTIVE. THE DETECTIVE PROVIDED THE FOLLOWING INFORMATION AS REPORTED TO HIM BY THE PATIENT'S MOTHER. THE PATIENT'S MOTHER STATED THAT THE PATIENT, A (B)(6), WAS "NOT FEELING WELL" ON (B)(6), 2011; THE PATIENT'S CONDITION DETERIORATED AND SHE EXPERIENCED THE SYMPTOMS OF VOMITING, DIARRHEA AND "BED-WETTING". ON (B)(6), 2011 AT 7:30 AM THE PATIENT OBTAINED TWO READINGS OF "HI MG/DL" (GREATER THAN 600 MG/DL) ON THE REPORTED METER. AT 7:22 AM THE PATIENT HAD OBTAINED TWO READINGS OF 324 MG/DL ON ANOTHER MANUFACTURER'S METER, AN ADVOCATE METER. THE PATIENT'S MOTHER REPORTEDLY HAD GIVEN HER INSULIN VIA AN INJECTABLE PEN "AT THE BEGINNING OF THE WEEK" (PRESUMABLY BETWEEN (B)(6), 2011) BUT CONFIRMED SHE DID NOT GIVE THE PATIENT ANY INSULIN ON (B)(6), 2011. THE PATIENT'S MOTHER DID NOT CONTACT EMERGENCY MEDICAL SERVICES. IT IS ESTIMATED THE PATIENT PASSED AWAY ON (B)(6), 2011. THE PATIENT'S BODY WAS DISCOVERED ON (B)(6), 2011 BY CHILD WELFARE WORKERS. AN AUTOPSY WAS PERFORMED AND THE CAUSE OF DEATH IS LISTED AS "UNDETERMINED" AWAITING RESULTS OF TOXICOLOGY TESTING. THE PATIENT HAD MULTIPLE BLOOD GLUCOSE METERS. THE LAST RESULTS IN THE MEMORY OF THE REPORTED METER WERE THE TWO NOTED "HI MG/DL" READINGS ON (B)(6), 2011, AND THE LATEST PREVIOUS READING IN MEMORY (507 MG/DL) WAS DATED (B)(6), 2011. THE ADVOCATE METER'S MEMORY LISTED ONLY THE (B)(6), 2011 RESULTS. THE LAST RESULTS IN ANOTHER METER, A ONETOUCH ULTRAMINI METER, WERE DATED (B)(6), 2011. THE PATIENT MANAGED HER DIABETES WITH AN INSULIN PEN. EITHER THE PATIENT OR THE MOTHER INJECTED INSULIN VIA THE PEN. THERE IS NO EVIDENCE THE PATIENT USED AN INSULIN PUMP, ALTHOUGH THE ONETOUCH ULTRALINK METER IS INTENDED TO BE USED WITH AN INSULIN PUMP WITH WHICH IT COMMUNICATES WIRELESSLY. THE DETECTIVE DID NOT HAVE THE PATIENT'S TEST STRIPS OR CONTROL SOLUTION, IF ANY. LITTLE IS KNOWN OF THE PATIENT'S HISTORY PRIOR TO HER DEATH. IT CANNOT BE DETERMINED AT THIS TIME IF THE REPORTED METER MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. THE PATIENT'S MOTHER STATED SHE DID NOT GIVE THE PATIENT INSULIN ON (B)(6), 2011 IN RESPONSE TO THE HIGH READINGS OBTAINED WITH THE REPORTED METER. THE METER HAD NOT BEEN USED BETWEEN (B)(6), 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Death