I-STAT CREA CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT #: (B)(4). THE INVESTIGATION WAS COMPLETED ON 08/28/2019. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING COULD NOT BE PERFORMED BEFORE THE LOT EXPIRED ON 09-AUG-2019. NO DEFICIENCY HAS BEEN IDENTIFIED.

Description of Event or Problem

NA.

Additional Manufacturer Narrative

APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Description of Event or Problem

ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT FOR ROUTINE FOLLOW UP CT SCAN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2019, COLLECTED: 08:09, TESTED: 08:09, RESULT: 1.6 MG/DL, SAMPLE: A. I-STAT, (B)(6) 2019, 08:42, 08:42, 0.7 MG/DL, B. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.