BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1670676 · Received April 30, 2010

    Report

    Report Number
    1823260-2010-02579
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    April 19, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. VANCOMYCIN RECOVERIES USING THE INTEGRA 800, P MODULE, AND TDX VANCOMYCIN APPLICATIONS CORRELATED WELL WITH THE VANCOMYCIN RESULT OBTAINED BY THE CUSTOMER. THE SAMPLE WAS ADDITIONALLY TESTED FOR VANCOMYCIN BY LC/MS/MS METHODOLOGY WHICH GENERATED A HIGHER VANCOMYCIN RESULT THEN THE OTHER VANCOMYCIN IMMUNOASSAY APPLICATIONS. THIS DIFFERENCE IN RECOVERY MAY BE DUE TO AN INTERFERING SUBSTANCE OR FACTOR PRESENT IN THE PATIENT SAMPLE. FURTHER INVESTIGATION COULD NOT BE CARRIED OUT DUE TO INSUFFICIENT SAMPLE VOLUME. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS RECEIVED REGARDING IMPACT TO THE PATIENT IN RELATION TO LOWERING OF THE VANCOMYCIN DOSAGE. "AS OF NOW, WE ARE NOT AWARE OF ANY ADVERSE EVENTS DUE TO LOWERING OF DOSE OR INCREASING THE INTERVAL BETWEEN DOSES OF VANCOMYCIN TO THE PATIENT". THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED INDICATING THE PHYSICIANS HAVE BEEN LOWERING THE PATIENT'S VANCOMYCIN DOSAGE. NO INFORMATION HAS BEEN PROVIDED REGARDING IMPACT TO THE PATIENT IN RELATION TO THE LOWERING OF THE VANCOMYCIN DOSAGE. THE INVESTIGATION IS ONGOING. THE VANCOMYCIN REAGENT LOT NUMBER WAS 620666.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR A SACROSPINOUS FIXATION PROCEDURE TO REPAIR VAGINAL PROLAPSE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE NURSE SUCCESSFULLY LOADED THE SIZE 0 CAPIO SUTURE (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORPORATION) INTO THE CAPIO DEVICE. HOWEVER, WHEN THE SUTURE WAS THROWN, THE CAPIO CAGE FAILED TO CATCH THE NEEDLE ATTACHED TO THE SUTURE. THE CAPIO DEVICE REPORTEDLY DID NOT COME IN CONTACT WITH THE PATIENT. IT WAS ALSO REPORTED THAT THE CAPIO DEVICE WAS NOT LABELED WITH AN EXPIRY DATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WITHOUT ANY COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY DOING "ABSOLUTELY FINE" POST-PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATELY ERRATIC READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. FOR APPROXIMATELY SIX MONTHS, THE PATIENT HAD OBTAINED BLOOD GLUCOSE READINGS ON THE REPORTED METER THAT SHE CLAIMED WERE INACCURATELY ERRATIC, SUCH AS 70 MG/DL AND 200 MG/DL. DURING THIS TIME PERIOD, THE PATIENT MANAGED HER DIABETES WITH INSULIN TAKEN ON A SLIDING SCALE. ON (B)(6) 2010 AT 1:00 AM, THE PATIENT EXPERIENCED THE SYMPTOMS OF COLD SWEATS AND TINGLING LEGS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE PATIENT'S TEST STRIPS WERE EXPIRED, AND THE METER WAS NOT PROGRAMMED FOR THE CORRECT CALIBRATION CODE NUMBER, BOTH OF WHICH CAN CAUSE INACCURATE READINGS. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT USED EXPIRED TEST STRIPS TO TEST HER BLOOD GLUCOSE LEVELS. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE TOOK INSULIN BASED ON BLOOD GLUCOSE READINGS FROM THE REPORTED METER. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER RECEIVED DISCREPANT VANCOMYCIN RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULT GAVE 35.4 MG/L. REPEAT TESTING WAS PERFORMED AT ANOTHER FACILITY ON (B) (6) 2010 ON A BECKMAN ANALYZER GIVING A RESULT OF 20.7 MG/L. THE CUSTOMER SAID THE BECKMAN VANCOMYCIN RESULT CORRELATES BETTER WITH PATIENTS CLINICAL SITUATION. INITIAL RESULT WAS REPORTED. NO INFORMATION PROVIDED IF PATIENT WAS ADVERSELY AFFECTED. .

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AT IMPLANT BECAUSE ¿IT DIDN¿T LOOK RIGHT.¿ REPORT RECEIVED FROM (B) (4) SALES REPRESENTATIVE VIA TELEPHONE. HE WAS NOTIFIED ON THE 11TH OF MAY THAT AN EXPLANT HAD TAKEN PLACE. HIS CONVERSATION WAS WITH THE NURSE, NURSE STATED THAT SURGEON EXPLANTED THE VALVE BECAUSE ¿IT DIDN¿T LOOK RIGHT ¿ THE LEAFLETS DIDN¿T LOOK RIGHT.¿ NO TEE WAS DONE AS THIS WAS ALL BEFORE ANY TESTING. NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED. SALES REPRESENTATIVE HAS NOT TALKED TO THE SURGEON AS HE IS ON VACATION BUT WILL TALK TO HIM NEXT WEEK. DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR VANCOMYCIN