BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1771761 · Received July 28, 2010

    Report

    Report Number
    2939301-2010-06010
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 20, 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 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 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

    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 SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE PATIENT DENIED HAVING ANY SYMPTOMS WHEN SHE OBTAINED THE "14.9 MMOL/L" METER READING. THE PATIENT REPORTEDLY PASSED OUT AT AN UNSPECIFIED TIME AFTER THE TEST FOR ABOUT 5 SECONDS. WHEN SHE WOKE UP, SHE FELT DIZZY AND SHAKY. SHE DENIED RECEIVING ANY TYPE OF INTERVENTION THAT WOULD INCREASE HER BLOOD GLUCOSE LEVELS BETWEEN HER "14.9 AND 21.9 MMOL/L" RESULTS. THE PATIENT WAS DISCHARGED FROM THE ER AT 7PM THE SAME DAY. BASED ON THIS ADDITIONAL INFORMATION, THIS COMPLAINT REMAINS REPORTABLE BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, PASSED OUT, AND RECEIVED TREATMENT AT THE ER AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE CUSTOMER SERVICE REPRESENTATIVE (CSR) WAS UNABLE TO REACH THE LAY USER/ PATIENT FOR FOLLOW-UP QUESTIONS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS CASE BASED ON CSR DOCUMENTATION. AT 1:45 PM ON (B)(6) 2010, THE PATIENT REPORTEDLY TESTED HER BLOOD GLUCOSE ON THE LFS METER AND OBTAINED A READING OF "14.9 MMOL/L." IT IS UNKNOWN IF THE PATIENT HAD ANY DIABETIC SYMPTOMS WHEN SHE TESTED ON THE SUBJECT METER OR IF SHE TOOK ANY ACTION BASED ON THE "14.9 MMOL/L" RESULT. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON (B)(6) 2010 AT 2:45 PM. THE CSR DOCUMENTED THAT THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (MEDICATION SPECIFICS WERE NOT PROVIDED). ABOUT THIRTY MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED THAT SHE PASSED OUT. IT IS UNKNOWN WHAT TIME THE PATIENT REGAINED CONSCIOUSNESS, BUT THE PATIENT STATED THAT SHE RETESTED HER BLOOD SUGAR ON THE LFS METER AT APPROXIMATELY 3:15 PM AND OBTAINED A READING OF "21.9 MMOL/L." IT IS UNKNOWN IF IN BETWEEN THE TESTS THERE WAS AN INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE PATIENT'S BLOOD GLUCOSE LEVEL. AT APPROXIMATELY 3:50 PM ON (B)(6) 2010, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER). THE PATIENT STATED THAT HER BLOOD GLUCOSE WAS TESTED ON THE ER METER (EXACT TIME UNSPECIFIED) AND OBTAINED A RESULT AROUND "4 MMOL/L." THE PATIENT REPORTED THAT SHE WAS GIVEN FOOD AND DRINK AS TREATMENT FOR HYPOGLYCEMIA. DURING THE TROUBLESHOOTING, THE CSR DOCUMENTED THAT MORE THAN 30 MINUTES ELAPSED IN BETWEEN THE REPORTED BLOOD GLUCOSE READINGS. 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 PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, LOST CONSCIOUSNESS, AND REQUIRED MEDICAL TREATMENT IN THE ER AFTER THE ALLEGED METER ISSUE BEGAN. HOWEVER, THERE IS NO EVIDENCE THAT THE SUBJECT METER WAS PERFORMING IMPROPERLY SINCE THE REPORTED BLOOD GLUCOSE RESULTS ARE INVALID FOR ACCURACY COMPARISON.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE ON (B)(6), 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 15MM (3ATM), 16.5MM (4.5ATM), AND 18MM (6ATM) IN THE PYLORIC PART. AT 6ATM, THE BALLOON BURST. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, AN AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 70 JOULES. NO PT INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN RT211 ADULT DUAL HEATED BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3010491

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R