BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1800565 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06640
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 9, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. 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

    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 FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER 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

    WHEN THE DOCTOR TRIED TO REPOSITION THE STENT, HE PULLED THE STENT BACK INTO THE 6FR BRITE TIP SHEATH AND THE STENT WAS STRIPPED OFF THE BALLOON. IT WAS RETRIEVED WITH A GOOSENECK SNARE. THERE WAS NO DIFFICULTY REMOVING THE STENT FROM THE PACKAGING AND PREPPING THE DEVICE. THERE WERE NO OTHER DEVICE ANOMALIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP HAD A BATTERY ISSUE. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. DURING REVIEW OF THE PUMP'S EVENT HISTORY, BAXTER PERSONNEL CONFIRMED THE REPORTED CONDITION AS A DEPLETED BATTERY ALARM AND DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT REPORTED THAT ON THE LATE EVENING OF (B)(4) 2010, HE BEGAN TO FEEL LIGHTHEADED, DIZZY AND SWEATY. AT APPROXIMATELY 10:47PM, HE TESTED HIS BLOOD GLUCOSE WITH THE SUBJECT METER IN RESPONSE TO THE SYMPTOMS AND OBTAINED A BLOOD GLUCOSE READING OF "6.7 MMOL/L (121 MG/DL)". THE PATIENT FELT THE RESULT WAS INACCURATELY HIGH BASED ON HOW HE WAS FEELING AND THEREFORE THEN TESTED WITH HIS ONETOUCH ULTRAMINI METER AND OBTAINED A READING OF "3.4 MMOL/L (61 MG/DL)". THE PATIENT STATED 5 MINUTES ELAPSED BETWEEN THE TWO TESTS. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 1.7MMOL/L. THE PATIENT REPORTED TREATING HIMSELF WITH JUICE IN RESPONSE TO THE LOW SYMPTOMS. PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT CLAIMED HE HAD LAST TESTED WITH THE SUBJECT METER PRIOR TO HIS DINNER (BETWEEN 6 AND 7PM). THE PATIENT DID NOT RECALL THE SPECIFIC RESULT OBTAINED AT THAT TIME, BUT INFORMED THE CSR THAT HE FELT IT WAS "A LITTLE HIGH" BASED ON HIS FEELINGS (FEELING NORMAL). THE PATIENT STATES HE TOOK BETWEEN 6 TO 8 UNITS OF NOVORAPID INSULIN BASED ON THE METER READING AND IT APPROXIMATELY 4 HOURS LATER IS WHEN HE FELT SYMPTOMATIC. THE PATIENT ALSO REPORTED THAT ON (B)(6) 2010, HE TESTED HIS BLOOD GLUCOSE AND OBTAINED BLOOD GLUCOSE READINGS OF "4.4 MMOL/L" WITH THE SUBJECT METER AND "5.9MMOL/L" ON THE ONETOUCH ULTRAMINI METER, PERFORMED WITHIN 1 MINUTE OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 1.7MMOL/L. THE PATIENT DENIED HAVING ANY SYMPTOMS AT THE TIME OF THIS TEST AND ALSO DENIED TAKING ANY ACTION REGARDING HIS DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED INACCURATE RESULT OBTAINED WITH THE SUBJECT METER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE REPORTED PRODUCTS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3024541

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R