THE CUSTOMER RECEIVED QUESTIONABLE CK-MB - THE MB ISOENZYME OF CREATINE KINASE STAT AND TROPONIN I STAT RESULTS FOR ONE PATIENT. THE INITIAL CKMB RESULT WAS 300 NG/ML WITH A DATA FLAG. THE INITIAL TROPONIN I RESULT WAS 25.00 NG/ML WITH A DATA FLAG. THE REPEAT CKMB RESULT WHEN DILUTED 1:10 WAS 41.28 NG/ML WITH A DATA FLAG. THE REPEAT TROPONIN I RESULT WHEN DILUTED 1:10 WAS 23.21 NG/ML WITH A DATA FLAG. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SECOND REPEAT CKMB RESULT WHEN DILUTED 1:10 WAS 404.7 NG/ML WITH A DATA FLAG. THE SECOND REPEAT TROPONIN I RESULT WHEN DILUTED 1:10 WAS 197.9 NG/ML WITH A DATA FLAG. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CKMB REAGENT LOT NUMBER WAS 174105 AND THE TROPONIN I REAGENT LOT NUMBER WAS 174423. THE EXPIRATION DATES WERE REQUESTED, BUT WERE NOT PROVIDED.
N
Patient 1
A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE PROVIDED CALIBRATION DATA, GENERAL REAGENT ISSUES WERE NOT SUSPECTED.
N
Patient 1
INFORMATION CONCERNING THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT WAS REQUESTED, BUT WAS NOT PROVIDED. THIS EVENT OCCURRED IN (B)(6).