BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1831731 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07671
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    510 (K) # IS K053529.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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.510(K) # IS K053529.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THERE WAS FIBER BREAKAGE AT 7,893 JOULES. NO PT INJURY WAS REPORTED. AN EXAMINATION, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE CAP WAS WORN OUT AND THE CAP REMAINED INTACT AND ATTACHED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6), 2010 ALLEGING INACCURATELY LOW READINGS ON THEIR ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE PATIENT ON (B)(6), 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT PRIOR TO TESTING ON (B)(6), 2010, AROUND NOON, HE DEVELOPED SYMPTOMS OF FEELING WEAK, NO CONTROL OVER HIS BODY AND UNABLE TO CROSS THE ROOM WITHOUT FALLING. THE PATIENT TESTED ON HIS METER AND OBTAINED A 181 MG/DL. THE PATIENT INCREASED HIS DOSAGE OF MEDICATION (PILLS) AND CONTACTED THE PARAMEDICS. APPROXIMATELY 30 MINUTES LATER, PARAMEDICS ARRIVED AND TESTED THE PATIENT'S BLOOD GLUCOSE ON THEIR METER AND OBTAINED A 545 MG/DL. DIFFERENCE BETWEEN HIS METER AND EMS'S METER WAS GREATER THAN 30 MG/DL (1.7 MMOL/L) OR 30% . PATIENT WAS NOT TREATED BY THE PARAMEDICS. THE PATIENT WAS TAKEN TO THE ER WHERE HE CLAIMS HE WAS NOT TREATED AT ALL AND WAS RELEASED A COUPLE 2-3 HOURS LATER. HE CLAIMS HE WAS KEPT IN THE ER FOR OBSERVATION. HIS READING 2 HOURS AFTER ARRIVING IN THE ER WAS AROUND 385 MG/DL. THE PATIENT MENTIONED THAT PRIOR TO THE SYMPTOMS, HE LASTED TESTED HIS BLOOD GLUCOSE EARLIER THAT MORNING AND OBTAINED A "NORMAL READING", WHICH WAS AROUND "90-120 MG/DL". THE TEST STRIPS WERE NOT EXPIRED AND WERE IN GOOD CONDITION. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCTS WERE REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED LOW READING ON HIS METER AND HAD TO CONTACT EMS AND WAS TAKEN TO THE ER FOR A BLOOD GLUCOSE RESULT OF 545 MG/DL ON THE EMS'S METER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FREEDOM LITE METER. CUSTOMER REPORTED RECEIVING READINGS OF 35 MG/DL, 229 MG/DL AND 58 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3041172

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening