BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT

    MDR report key: 1500681 · Received October 12, 2009

    Report

    Report Number
    2015691-2009-11779
    Event Type
    Injury
    Date Received
    October 12, 2009
    Date of Event
    July 27, 2009
    Report Date
    September 14, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. TWO REQUESTS WERE MADE (VIA E-MAIL) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    ON OCTOBER 1, 2009, THE LAY-USER/REPORTER CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE REPORTER ON OCTOBER 7, 2009, AND WAS ABLE TO OBTAIN/VERIFY INFORMATION. THE PATIENT MANAGES HIS DIABETES WITH SLIDING-SCALE HUMULIN 70/30 INSULIN BASED ON HIS METER READINGS. THE REPORTER INDICATED THAT THE ALLEGED ISSUE BEGAN ON THE DAY OF EVENT AT 12:22 PM. AT THAT TIME, THE PATIENT OBTAINED A RESULT OF "233 MG/DL." RESULTS OF "191, 233, 244, AND 233 MG/DL" WERE VERIFIED IN THE REPORTED METER'S MEMORY. BASED ON THE METER READING OF "233 MG/DL," THE PATIENT TOOK 40 UNITS OF HUMULIN 70/30 INSULIN BASED ON HIS SLIDING-SCALE REGIMEN AT 12:30 PM. AN UNSPECIFIED TIME LATER THAT DAY, THE REPORTER CLAIMED THAT THE PATIENT DROPPED LOW AND HAD SYMPTOMS OF DIZZINESS, CONFUSION, AND SWEATY SKIN. THE PATIENT TESTED HIS BLOOD GLUCOSE WHILE FEELING LOW AND GOT "80 SOMETHING." ACCORDING TO THE REPORTER, THE PATIENT EXPECTED A BLOOD GLUCOSE READING THAT WAS LOWER. HE FELT AS THOUGH THE RESULT OF "80 SOMETHING" WAS STILL TOO HIGH COMPARED TO HOW HE FELT. THE PATIENT ADMINISTERED SELF-TREATMENT BY EATING A SANDWICH AND DRINKING JUICE. HE FELT BETTER AFTER THE SELF-CARE WAS TAKEN. ACCORDING TO THE REPORTER, THE PATIENT WAS USING A CORRECT TECHNIQUE FOR TESTING WITH THE REPORTED METER. THE PATIENT WAS OBTAINING BLOOD SAMPLES FROM HIS FINGERS AND CLEANING THE PUNCTURE SITES CORRECTLY. 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 REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER TAKING INSULIN BASED ON A METER READING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER A IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4625 R-08M2702

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention