I-STAT CREA CARTRIDGE

Additional Manufacturer Narrative

(B)(4). APOC LABELING WAS EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. THE INVESTIGATION WAS COMPLETED ON 11/10/2016. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED TEST DATA MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. Z (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY WAS IDENTIFIED. ASSESSMENT: NO REPEATS ON THE I-STAT. THE COMPLAINT INVESTIGATION CONCLUDED THERE WAS NO PRODUCT DEFICIENCY AND THAT THE I-STAT CARTRIDGE LOT IS MEETING SPECIFICATION.

Description of Event or Problem

ON (B)(6) 2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREATININE RESULT ON A (B)(6) MALE PATIENT WITH TYPE 2 DIABETIC IN FOR A CT SCAN. THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT, THE PATIENT WAS TREATED BASED ON THE LAB RESULTS. THERE WAS NO REPEAT ON I-STAT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT ISNOT AVAILABLE FOR INVESTIGATION. (B)(6). AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC, HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE ((B)(4)).