BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1770771 · Received July 27, 2010

    Report

    Report Number
    2939301-2010-05942
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 10, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. 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

    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

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR TWO PATIENT SAMPLES UPON REPEAT, BOTH SAMPLES RESULTED IN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT REPORT ANY PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE REPORTER/PATIENT'S GRANDSON CONTACTED LIFESCAN (LFS) ALLEGING THAT THE LAY USER/PATIENT'S ONETOUCH ULTRA METER WAS DISPLAYING AN "ER 2' MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THE FOLLOWING COMPLAINT BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER ALLEGED THAT THE PRODUCT ISSUE BEGAN ON (B)(6) 2010 (TIME UNSPECIFIED). IT IS NOT KNOWN WHEN THE PATIENT LAST TESTED HER BLOOD GLUCOSE AND WHAT READINGS SHE WAS OBTAINING FROM THE ALLEGED METER PRIOR TO WHEN THE ISSUE STARTED. THE CCA DOCUMENTED THAT THE PATIENT MANAGES HER DIABETES WITH 500 MG METFORMIN AND 5 MG GLYBURIDE. ON (B)(6) 2010, THE REPORTER CLAIMED THAT THE PATIENT SKIPPED HER AFTERNOON DOSE OF METFORMIN DUE TO THE ALLEGED ISSUE. ON AN UNSPECIFIED TIME ON (B)(6) 2010, THE REPORTER STATED THAT THE PATIENT BECAME "SWEATY AND DIZZY." THE REPORTER DENIED THAT THE PATIENT USED ANY OTHER METER TO TEST HER BLOOD GLUCOSE. THE PATIENT REPORTEDLY TREATED HERSELF WITH FOOD AND DRINK. DURING THE TROUBLESHOOTING SESSION, THE CCA VERIFIED THAT THE ALLEGED ERROR MESSAGE OCCURRED WHEN THE POWER BUTTON WAS PRESSED. THE REPORTED ISSUE COULD NOT BE RESOLVED BY THE END OF THE CALL. REPLACEMENT METER AND SUPPLIES WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING CLASSIFIED AS MDR-REPORTABLE DUE TO THE FOLLOWING CONCLUSION(S): THE REPORTER CLAIMS THAT THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3010691

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R