STATSENSOR CREATININE TEST STRIPS

Description of Event or Problem

ON (B)(6) THE CUSTOMER PERFORMED A QUICK CREATININE TEST USING THE SSXPI FOR A PATIENT WHOSE CONDITION WAS NOT VERY GOOD, AND A SIGNIFICANT DISCREPANCY WAS OBSERVED COMPARED TO THE OUTSOURCED LABORATORY ANALYZER. STATSTRIP XPRESS CREA = 0.88 MG/DL. OUTSOURCED LABORATORY ANALYZER: CREA = 1.74 MG/DL. SINCE THE CREATININE VALUE MEASURED BY THE STATSTRIP XPRESS WAS JUST WITHIN THE NORMAL RANGE, THE CUSTOMER PROCEEDED WITH CONTRAST AGENT ADMINISTRATION FOR THE PATIENT. HOWEVER, BECAUSE THE PATIENT'S CONDITION WAS ORIGINALLY POOR, THE AMOUNT OF CONTRAST AGENT ADMINISTERED WAS REDUCED TO 80% OF THE USUAL DOSE (100 ML). AS OF OCTOBER 16, NO ADVERSE HEALTH EFFECTS HAD BEEN OBSERVED IN THE PATIENT. QC TESTING: THE CUSTOMER DIDN'T PERFORM QC TESTING BEFORE/AFTER THIS INCIDENT WITHIN 24 HOURS. HANDLING OF TEST STRIPS: THEY SAID THE TEST STRIP IN QUESTION APPEARS TO HAVE BEEN OPENED WITHIN THE LAST MONTH. THEY STORED TEST STRIPS IN THE REFRIGERATOR AFTER OPENING AND WERE RETURNED TO REFRIGERATED STORAGE AFTER EACH USE. THEY ALSO FAILED TO ALLOW THE TEST STRIP VIALS TO EQUILIBRATE TO ROOM TEMPERATURE FOR TWO HOURS BEFORE OPENING. BLOOD SAMPLING. BOTH THE SAMPLES FOR THE STATSTRIP XPRESS AND FOR OUTSOURCED TESTING WERE TAKEN FROM VENOUS BLOOD DRAWN USING A SYRINGE AFTER SECURING AN INTRAVENOUS LINE. SINCE THE SYRINGE IS CONNECTED IMMEDIATELY AFTER INSERTING THE ELASTER NEEDLE AND BLOOD IS DRAWN BEFORE CONNECTING THE IV DRIP, THERE IS NO POSSIBILITY OF THE INFUSION SOLUTION MIXING WITH THE BLOOD SAMPLE.

Additional Manufacturer Narrative

FUNCTIONAL INVESTIGATION: 3-1. PERFORMANCE CHECK OF THE METER: UPON CHECKING THE EXTERNAL APPEARANCE OF THE METER IN QUESTION (S/N: (B)(6)), WE CONFIRMED THAT THERE ARE MINOR SCRATCHES ON THE SCREEN AND DRIED BLOOD AT TEST STRIP INSERTION PORT. ALSO, UPON INSERTION OF THE TEST STRIP IN THE RECEIVED CONDITION, WE CONFIRMED THAT THE METER STARTED UP NORMALLY AND COULD BE TESTED. IN THIS CONDITION, USING THIS METER AND OUR TEST STRIPS RETAINED (LOT NO. 4925059129), WE PERFORMED DUPLICATE MEASUREMENTS OF CREATININE QC SOLUTION LEVELS 1 TO 3 IN QC MEASUREMENT MODE. AS A RESULT, WE CONFIRMED THAT ALL MEASURED VALUES WERE WITHIN THE QC ACCEPTABLE CONTROL ASSAY RANGE. 3-2. PERFORMANCE CHECK OF TEST STRIPS USING THE TEST STRIPS IN QUESTION (LOT NO. 4925059129), WE PERFORMED DUPLICATE MEASUREMENTS IN THE QC MEASUREMENT MODE USING THE CREATININE QC SOLUTION (LEVEL 1-3) AS SAMPLES USING OUR REFERENCE METER (S/N: (B)(6)) AND METER IN QUESTION (S/N: (B)(6)). UPON INSERTION OF THE TEST STRIP, OUR REFERENCE METER AND THE METER IN QUESTION POWERED ON NORMALLY AND SUCCESSFULLY PERFORMED THE QC SOLUTION MEASUREMENT. AS A RESULT, ALL MEASURED VALUES WERE CONFIRMED TO BE WITHIN THE RANGE INDICATED BY THE QC SOLUTION. IN ADDITION, IN ORDER TO CONFIRM THE EFFECT OF MOISTURE ABSORPTION OF THE TEST STRIPS, WE WEIGHED THE VIAL IN QUESTION AND OUR OWN TEST STRIP VIALS AND COMPARED THEIR WEIGHTS. THE (EMPTY) WEIGHT OF THE VIAL WE RECEIVED WAS 16.50G. THE AVERAGE (EMPTY) WEIGHT OF THE TWO UNOPENED VIALS RETAINED (LOT NO. 4925059129) WAS 16.39 G. THE DIFFERENCE BETWEEN THE WEIGHT OF THE TEST STRIP VIAL IN QUESTION AND THE AVERAGE WEIGHT OF OUR TEST STRIP VIALS RETAINED WAS 0.11 G. THIS WEIGHT DIFFERENCE WAS WITHIN THE ACCEPTABLE RANGE (LESS THAN 0.25 G) SPECIFIED BY NOVA BIOMEDICAL CORPORATION. THIS SUGGESTED THAT THE TEST STRIPS IN QUESTION WERE NOT AFFECTED BY MOISTURE ABSORPTION. 3-3. VERIFICATION USING FINGERSTICK BLOOD WITH THE TEST STRIPS IN QUESTION, WE PERFORMED DUPLICATE MEASUREMENTS OF FINGERSTICK BLOOD SAMPLES FROM OUR VOLUNTEERS USING THE METER IN QUESTION AND OUR REFERENCE METER. AS A RESULT, WE CONFIRMED THAT NEARLY EQUIVALENT MEASUREMENT VALUES WERE OBTAINED BETWEEN THE TWO METERS. 4. CONCLUSION: AS A RESULT OF THE ABOVE INVESTIGATION, WE HAVE CONFIRMED THAT THERE IS NO PROBLEM WITH THE MEASUREMENT PERFORMANCE OF THE METER AND TEST STRIPS WE RECEIVED, AS THE REPORTED EVENT COULD NOT BE REPRODUCED, THE MEASUREMENT RESULTS OF THE QC SOLUTION WERE STABLE WITHIN THE DISPLAY RANGE, AND THE MEASUREMENT RESULTS OF THE FINGERTIP BLOOD SAMPLES USING THE METER IN QUESTION AND OUR OWN METER WERE ALMOST IDENTICAL. BASED ON THE INTERVIEW BY OUR TECHNICAL SERVICE TEAM, WE LEARNED THAT NO QC SOLUTION TESTING WAS PERFORMED ON THE DATE THE REPORTED EVENT OCCURRED. THEREFORE, IT IS POSSIBLE THAT THE USER USED UNVERIFIED TEST STRIPS, AND THAT THERE WAS NO PROBLEM WITH THE METER USED, BASED ON THIS FACT AND OUR VERIFICATION RESULTS. ALSO, THE ABNORMAL RESULTS REPORTED COULD BE RELATED TO THE TEST STRIP VIALS BEING LEFT OPEN, OR THEY COULD BE RELATED TO PRE-ANALYTICAL ISSUES SUCH AS LOW BATTERY VOLTAGE, OR PROBLEMS WITH THE BLOOD COLLECTION SITE, PATIENT HISTORY, OR MEDICATIONS TAKEN. OR OTHER PRE-ANALYTICAL ISSUES.