BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3023096 · Received March 27, 2013

    Report

    Report Number
    3008382007-2013-06351
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K002134
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING, RESULT MET SPECIFICATION, NO FAULTS WERE FOUND, AND THE METER FUNCTIONED PROPERLY. PA UNABLE TO REPRODUCE THE COMPLAINT.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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) 2013, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS GIVING INACCURATELY LOW READINGS. ON (B)(6) 2013, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. ON (B)(6) 2013, AT 11:00 PM THE PATIENT BEGAN TO EXPERIENCE THE SYMPTOMS OF SHAKING, SWEATING AND UNCONSCIOUSNESS. THE PATIENT'S WIFE DID NOT PROVIDE HIM ANY TREATMENT, AND CONTACTED EMERGENCY SERVICES. BETWEEN 11:0 PM AND 11:30 PM, PARAMEDICS ARRIVED AND TREATED THE PATIENT WITH AN UNSPECIFIED INJECTION. AT 11:30 PM, PARAMEDICS TESTED THE PATIENT'S BLOOD GLUCOSE LEVEL USING THE PATIENT'S OWN METERS, AND OBTAINED THE BLOOD GLUCOSE READING OF 145 MG/DL ON THE REPORTED METER AND A READING OF 178 MG/DL ON THE PATIENT'S BACKUP METER, A ONETOUCH ULTRAEASY METER. THE PATIENT REGAINED CONSCIOUSNESS AND WAS NOT TRANSPORTED TO THE EMERGENCY ROOM. EARLIER ON THE DAY OF THIS EVENT, THE PATIENT HAD BEEN ILL WITH A COLD. HE HAD EATEN DINNER OF BREAD, CHEESE AND SAUSAGE. THE PATIENT HAD OBTAINED THE BLOOD GLUCOSE READINGS ON THE REPORTED METER OF 172 MG/DL IN THE MORNING, 198 MG/DL AT NOON, 208 MG/DL IN THE AFTERNOON, AND 56 MG/DL IN THE EVENING. THE PATIENT NOTED HE HAD TAKEN THE DOSES OF "HUM-INSULIN" 27.0 UNITS MORNING, 25.0 UNITS NOON AND 28.0 UNITS EVENING. THE PATIENT MANAGES HIS DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. THE PATIENT'S EXPECTED BLOOD GLUCOSE READINGS RANGE FROM 90 MG/DL TO 130 MG/DL. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THERE IS NO EVIDENCE THE REPORTED METER WAS NOT FUNCTIONING APPROPRIATELY. THE METER READING CORRELATED WITH THE RESULT OBTAINED ON A BACKUP METER, AND THE EVENING READING OF 56 MG/DL CORRELATED WITH THE PATIENT'S SUBSEQUENT SEVERE HYPOGLYCEMIC SYMPTOMS. THE ELEVATED METER READINGS OF 145 MG/DL WAS OBTAINED AFTER THE PARAMEDICS TREATED THE PATIENT WITH AN INJECTION. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE INJURY WHILE USING THE METER, AND RECEIVED EMERGENCY MEDICAL ATTENTION AND TREATMENT, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126956 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3353100

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R