FDA Adverse Event Injury Summary report: N

SIEMENS-BAYER HEALTHCARE DIAGNOSTICS INC.

MDR report key: 1044649 · Received May 12, 2008

Report

Report Number
MW5006834
Event Type
Injury
Date Received
May 12, 2008
Date of Event
April 14, 2008
Report Date
May 12, 2008
Product Code
JJE
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

AN ENTIRE RUN OF POTASSIUM RESULTS RUN ON THE SIEMENS ADVIA 1650 WERE 10.1% ON AVERAGE TOO HIGH. AN ENTIRE DAY'S RUN OF 90 SERUM SAMPLES WERE CORRECTED. THIS INCLUDES 3 PANIC VALUES THAT WERE CHANGED TO ABNORMAL HIGH, THREE OTHER HIGH PATIENT RESULTS STAYED HIGH, ONE NORMAL RESULT THAT BECAME LOW, 18 HIGH RESULTS BECAME NORMAL AND THE REMAINING RESULTS WERE NORMAL TO NORMAL VALUES. THE SAMPLES WERE DRAWN IN BD SST 5ML 13X100 TUBES, LOT 8036897 EXP 1/09. I DON'T FEEL THIS WAS PROBLEMATIC BECAUSE DATA ON OUR INTERNAL PT CONTROL FOR FEB-MAR SHOWED ONLY A 0.1% DIFFERENCE FROM LATE AFTERNOON TO NEXT MORNING ON THIS ANALYTE IN USE LOTS WITH ACCEPTABLE EXPIRATION DATES USED: K ELECTRODE LOT 32871, EXP 5/31/2008, LO CAL 55714AL, 4/30/2008, HI CAL 55714AH, 4/30/2008, ISE, 8/31/2008, INTERNAL SOLN 1186121 6/30/2008, BUFFER DP747AA 2/28/2009, AND DETERGENT 00126634 9/30/2008. THE CALIBRATION WAS ACCEPTABLE ALTHOUGH IN RETROSPECT THERE WAS AN OBVIOUS DOWNWARD "BLIP" IN K ON THE GRAPHS ON THE ISE MONITOR PAGE ON THE ANALYZER. THE SIGNIFICANCE OF THE "BLIPS" IS UNK AND NOT ADDRESSED BY SIEMENS. THERE WERE NO ERROR FLAGS ON THE CALIBRATION REPORT. CONTROLS WERE WELL WITHIN ACCEPTABLE LIMITS. THE FIRST TWO SAMPLES THAT HAD PRIOR VALUES "PULL UP FOR REFERENCE" PRIOR RESULTS WITHIN THE LAST 30 DAYS WERE ACTUALLY LOWER THAN PRIOR RESULTS, BUT AFTER THAT THE OTHER 15 WERE ALL HIGHER. IT SEEMS SOMETHING OCCURRED EARLY IN THE DAY THAT INVOLVED JUST THIS ANALYTE THAT WENT UNNOTICED UNTIL SUPERVISORY REVIEW THE NEXT DAY WHERE ELEVATED K RESULTS WERE FOUND TO BE GREATLY INCREASED FROM A NORMAL DAY'S RUN. THERE WAS NO ERROR CODES ON THE SYSTEM LOG TO INDICATE A PROBLEM. ALTHOUGH SIEMENS SERVICE WAS IN 2 DAYS AFTER THE EVENT AND FOUND A LEAKY ISE SYRINGE, WE DID NOT FEEL THIS WAS THE PROBLEM SINCE IT "CORRECTED ITSELF" BY THE PRIOR DAY WITH ONLY ROUTINE DAILY SHUTDOWN WASH AND MORNING CALIBRATION WAS DONE BY STAFF DURING NORMAL INSTRUMENT SET UP. THE SODIUM AND CHLORIDE WERE NOT AFFECTED, NOR WERE THE VALUES ERRATIC WHICH WOULD BE SEEN WITH IMPROPER SYRINGE DELIVERY. WE DID NOTICE AN ABNORMAL DIFFERENCE OF 0.6 MEQ/L ON OUR INTERNAL PT CONTROL FROM THE DAY OF THE INCIDENT TO THE FOLLOWING MORNING AFTER THE FACT. SIEMENS FELT THIS WAS AN ISOLATED EVENT. THEY SUGGESTED THE USE OF DELTA CHECKS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SIEMENS-BAYER HEALTHCARE DIAGNOSTICS INC. ADVIA 1650 CHEMISTRY ANALYZER JJE 1650

Patients

Seq Age Sex Outcome Treatment
1 Other