BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1890447 · Received November 3, 2010

    Report

    Report Number
    2939301-2010-09680
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 30, 2010
    Report Date
    October 30, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 TESTING WITH NO FAULTS FOUND. 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

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 12/10/2010: 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.

    Additional Manufacturer Narrative · 1

    THE 510K # IS K062195. 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) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT ON (B)(6) 2010 AT APPROXIMATELY 8:00AM HE WOKE UP FEELING LIGHTHEADED AND SWEATY; SYMPTOMS HE ASSOCIATED WITH LOW BLOOD GLUCOSE. AT THE ONSET OF SYMPTOMS HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED AN ALLEGED INACCURATE HIGH READING OF "161 MG/DL". THE PATIENT DID NOT FEEL THAT THE RESULT CORRELATED WITH HOW HE WAS FEELING AND THEREFORE IMMEDIATELY TESTED WITH HIS BACKUP METER AND OBTAINED A READING OF "78 MG/DL". THE PATIENT CONFIRMED BOTH TESTS WERE TAKEN JUST A COUPLE OF MINUTES APART FROM EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR 30 MG/DL. THE PATIENT CLAIMED HE ATE SOMETHING IN RESPONSE TO THE SYMPTOMS AND CONFIRMED FEELING BETTER AFTERWARDS. PRIOR TO DEVELOPING THE SYMPTOMS, THE PATIENT REPORTED THAT HE HAD LAST TESTED WITH THE SUBJECT METER THE NIGHT BEFORE AT 11:00PM (BEFORE GOING TO SLEEP). THE PATIENT STATED HE OBTAINED A RESULT IN THE "200 MG/DL RANGE" WHICH WAS UNUSUAL FOR HIM, SINCE HE GENERALLY TESTS IN THE "150 MG/DL" RANGE. IN RESPONSE TO THE HIGH RESULT, THE PATIENT CLAIMED HE TOOK 2 ADDITIONAL UNITS OF LANTUS INSULIN AND 4 UNITS OF HUMALOG INSULIN. THE PATIENT FELT THAT HIS SYMPTOMS MAY HAVE BEEN A RESULT OF TAKING MORE INSULIN THAN HE NEEDED BASED ON THE SUBJECT METER'S RESULT. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT ITEMS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    DURING CIRCUMCISION WITH GOMCO, IT BECAME DIFFICULT TO REMOVE THE FORESKIN FROM THE PENIS. THIS CAUSED A SPLITTING TEAR AT THE FORESKIN INCISION JUNCTION REQUIRING SIX SUTURES TO CLOSE.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2010 ALLEGING THAT HIS ONE TOUCH ULTRA METER POWERS OFF DURING USE. THE PATIENT HAS HAD THE METER FOR APPROXIMATELY 10 MONTHS AND TESTS 4X A DAY. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT MENTIONED THAT THE ALLEGED ISSUE WITH METER HAPPENS RIGHT AFTER THE CODE NUMBER APPEARS ON THE METER. THE ISSUE BEGAN ON (B)(6) 2010. SHORTLY AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS WHERE HE FELT SLEEPY, SWEATING, URINATION, "PINS AND LOSS OF FEELING ON THE ARMS" AND THE PATIENT EVENTUALLY FAINTED. THE PATIENT WAS TAKEN TO THE HOSPITAL BY HIS WIFE AND WAS TREATED WITH INSULIN AND ORAL MEDICATION. PATIENT REGAINED CONSCIOUSNESS 4-5 HOURS LATER. WHEN THE PATIENT REGAINED CONSCIOUSNESS HE WAS TOLD HIS BLOOD GLUCOSE WAS 450 MG/DL AFTER HE HAD REGAINED CONSCIOUSNESS. HE WAS ADMITTED IN THE HOSPITAL FOR 2 DAYS. PATIENT WAS NOT GIVEN A DIAGNOSIS AND HIS DIABETES REGIMEN WAS NOT CHANGED BECAUSE OF THE INCIDENT. THERE WAS NO MISUSE OF THE PRODUCT AND THE BATTERIES DID NOT NEED TO BE REPLACED. THE LAST READING THE PATIENT OBTAINED ON HIS METER WAS TWO DAYS BEFORE THE ALLEGED ISSUE BEGAN AND OBTAINED A 170 MG/DL. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE METER POWERING OFF DURING USE, THE PATIENT WAS UNABLE TO TEST, DEVELOPED SYMPTOMS, AND HAD TO BE HOSPITALIZED AND TREATED FOR 2 DAYS FOR A BLOOD GLUCOSE OF 450 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3034684

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R