BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1760733 · Received July 19, 2010

    Report

    Report Number
    2939301-2010-05722
    Event Type
    Injury
    Date Received
    July 19, 2010
    Report Date
    July 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. 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

    (B)(4). 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

    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

    (B)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRA METER READ INACCURATELY. THE PATIENT INDICATED THAT THE ALLEGED ISSUE STARTED ON AN UNSPECIFIED DATE/TIME WITHIN THE PAST 4 YEARS. THE PATIENT REPORTED A METER READING OF "117 MG/DL" BUT IT IS NOT KNOWN WHAT DATE/TIME THE RESULT WAS OBTAINED. ACCORDING TO THE CUSTOMER SERVICE REPRESENTATIVE (CSR), THE PATIENT HAD BEEN USING EXPIRED TEST STRIPS DURING THE TIME OF CONCERN. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT SHE HAD DEVELOPED SYMPTOMS OF WEAKNESS AND SWEATING ON AND OFF FOR THE PAST 4 YEARS ALSO. THE PATIENT DENIED THAT SHE RECEIVED ANY TREATMENT BECAUSE OF THE ALLEGED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HER MEDICATION AND DIABETES MANAGEMENT REGIMENS, WHAT METER READINGS THE PATIENT OBTAINED BEFORE AND AFTER THE SYMPTOMS DEVELOPED, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER THE SYMPTOMS STARTED. THE PATIENT DID NOT HAVE CONTROL SOLUTION FOR TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED A SYMPTOM OF SWEATING WHICH CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Description of Event or Problem · 1

    MILESTONE EM MICROWAVE PROCESSOR. NEAR THE END OF THE PROCESSING RUN, DURING THE TOLUENE STEP (TRANSITIONAL SOLVENT), A LAB TECHNICIAN DETECTED A BURNING PLASTIC ODOR COMING FROM THE PROCESSOR. HE IMMEDIATELY TERMINATED THE PROGRAMMED STEP AND TURNED OFF THE MACHINE. THE PLASTIC VIAL (HOLDING THE SPECIMEN BASKETS) WAS PARTIALLY MELTED AND THE SOLVENT (TOLUENE) IN THE VIAL WAS DISCOLORED. SOME OF THE SOLVENT WAS FORCED OUT OF THE VIAL INTO THE SURROUNDING MICROWAVE CHAMBER. NORMALLY, THE TOLUENE WOULD REMAIN COLORLESS AFTER THIS STEP. ALSO, THE SPECIMEN BASKETS CONTAINED WITHIN THE VIAL WERE PARTIALLY MELTED/DISTORTED. IT IS NOT KNOWN WHETHER, OR TO WHAT EXTENT, THE TISSUE SPECIMENS (8 RENAL BIOPSIES) SUFFERED HEAT DAMAGE DURING THE MALFUNCTION. IF THERE WAS ENOUGH ENERGY TO DAMAGE THE PLASTIC PARTS, THERE MAY HAVE BEEN TISSUE COMPROMISE (I.E. COOKED).====================== HEALTH PROFESSIONAL'S IMPRESSION======================A SPINDLE WITHIN THE MICROWAVE DEVICE HOLDS THE SPECIMEN BASKETS, AND ACCORDING TO THE MANUFACTURER AFTER THE FACT HAD "EXPIRED." THE OSMIUM USED IN THE PROCESS PENETRATES AND COATS THE SPINDLE, AND EVEN WITH VIGILANT CLEANING IT MUST BE REPLACED PERIODICALLY. IN THIS CASE THE EXPOSED SPINDLE ACTED LIKE A METAL OBJECT INTHE MICROWAVE AND ARCED. THE LAB HAD A NEW SPINDLE THAT WAS USED FOR A SECOND TEST RUN WITH NORMAL RESULTS. THE MANUFACTURER INFORMED OUR FACILITY THAT WITH VIGILANT CLEANING, THE SPINDLES SHOULD EACH LAST 3 MONTHS. THERE WAS NO PREVIOUS MENTION OF NEEDING TO REPLACE "EXPIRED" SPINDLES. TECHNICIAN'S RECORD OF THE EVALUATION: THE TOLUENE STEP USING THE EXISTING SPINDLE DURING THE 5 MINUTE "STEP" PRODUCED VERY OBVIOUS SPARKING WITHIN THE SPECIMEN VIAL AND THE SOLVENT BECAME DISCOLORED. THE SAME STEP WAS RUN WITH A NEW SPINDLE AND THERE WAS NO OBVIOUS SPARKING AND THE SOLVENT REMAINED COLORLESS, AS NORMAL. THE INSTRUMENT SEEMED TO HAVE DIFFICULTY REACHING THE APPROPRIATE TEMPERATURE . THIS MAY HAVE BEEN DUE TO THE ABSENCE OF SPECIMENS.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EXTENDED CHARGE TIMES EXCEEDING THE EXTENDED CHARGE TIME LIMIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3027259

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening