STATSENSOR CREATININE TEST STRIPS

Description of Event or Problem

"ON SEPTEMBER 30, WE WERE INFORMED BY THE CUSTOMER OF A DISCREPANCY IN CREATININE MEASUREMENT VALUES. SSXPI: CREA = 0.93 MG/DL, EGFR = 60.8. IN-HOSPITAL ANALYZER: CREA = 1.43 MG/DL, EGFR = 38. SINCE THE CREATININE VALUE MEASURED BY SSXPI WAS 0.93, THE CUSTOMER ADMINISTERED CONTRAST MEDIUM TO THE PATIENT. AFTER SUBSEQUENTLY RECEIVING THE LABORATORY RESULT OF 1.43, THE PHYSICIAN ADMINISTERED AN ADDITIONAL 500 ML OF SALINE SOLUTION TO DILUTE THE CONTRAST MEDIUM CONCENTRATION IN THE BODY. AS OF ON (B)(6), NO HEALTH HAZARD HAS BEEN OBSERVED IN THE PATIENT. THE CUSTOMER PERFORMS QC TESTING ONCE A MONTH; HOWEVER, IT WAS NOT PERFORMED ON THE DAY OF THE INCIDENT. REGARDING TEST STRIPS: THE TEST STRIPS USED WERE OPENED ON (B)(6) (EXPIRATION DATE AFTER OPENING: AUGUST 30, THEREFORE EXPIRED). THEY WERE STORED IN A REFRIGERATOR AND BROUGHT BACK TO ROOM TEMPERATURE FOR ABOUT HALF A DAY BEFORE USE. THE CUSTOMER HAS ALREADY DISCARDED THE TEST STRIP VIAL IN QUESTION. REGARDING BLOOD SAMPLING: THE MEASUREMENT WAS PERFORMED ON A BLOOD SAMPLE COLLECTED FROM THE ARM. IT IS UNKNOWN WHETHER AN ANTICOAGULANT WAS USED, AND IF SO, WHICH TYPE WAS USED."

Additional Manufacturer Narrative

ALTHOUGH THE METER IN QUESTION IS NOT AVAILABLE IN THE US, THE STRIPS ARE SOLD IN THE US. RETAINED AND RETURNED NOVA STATSENSOR CREATININE I TEST STRIPS (LOT#: 4924337129) WERE TESTED FOR THIS STUDY. TESTING INCLUDED FIVE (5) NOVA STATSENSOR CREATININE LINEARITY SOLUTIONS AND FIVE (5) LEVELS OF BLOOD SAMPLES FROM CONSENTING ADULT DONORS. FOUR (4) NOVA STATSENSOR CREATININE I EXPRESS METERS WERE USED, AS WELL AS ONE (1) RETURNED NOVA STATSENSOR CREATININE I EXPRESS METER FOR FOUR (4) MEASUREMENTS OF EACH SAMPLE (20 MEASUREMENTS) FOR RETAINED TEST STRIPS. IN ADDITION, ONE (1) RETURNED NOVA STATSENSOR CREATININE I TEST STRIPS (LOT#: 4924337129) WAS TESTED ON BLOOD SAMPLES. SIEMENS EXL ANALYZER WAS USED FOR BLOOD SAMPLE REFERENCE VALUES. RETAINED NOVA STATSENSOR CREATININE I TEST STRIPS (LOT#: 4924337129) PASSED ALL ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SAMPLES. RESULTS FOR LINEARITY SOLUTIONS ARE ALL WITHIN THE LINEARITY SOLUTION RANGES. NO DISCREPANCIES WERE OBSERVED BETWEEN RETAINED NOVA STATSENSOR CREATININE I TEST STRIPS (LOT#: 4924337129) BLOOD RESULTS AND THE SIEMENS EXL ANALYZER. THERE WERE ALSO NO DISCREPANCIES OBSERVED USING THE RETURNED NOVA STATSENSOR CREATININE I EXPRESS METER. ADDITIONALLY, THE ONE RETURNED CREATININE I TEST STRIP (LOT#: 4924337129) SHOWED A LOW RESULT BUT THAT IS MOST LIKELY BECAUSE IT APPEARED TO NOT HAVE BEEN REFRIGERATED AT ALL EN ROUTE TO THE FACILITY FOR TESTING. ADDITIONALLY, THE STRIPS IN QUESTION WERE EXPIRED AS THE CUSTOMER REPORTED THEY HAD BEEN USED OVER 90 DAYS AFTER THEY HAD INITIALLY BEEN OPENED, AND THIS IS THE MOST LIKELY ROOT CAUSE OF THE DISCREPANT RESULTS BEING REPORTED. DHR REVIEWS WERE PERFORMED ON THE REPORTED METER AND STRIP LOT. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR'S INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.