I-STAT CREA CARTRIDGE

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) 2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREATININE RESULT OF <0.2 MG/DL ON A 50 YEAR OLD MALE PATIENT WITH ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE CUSTOMER ALSO REPORTS THAT THE PATIENT WAS GIVEN CONTRAST BASED ON ONE I-STAT RESULT OF <0.2 MG/DL. THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(6) 2022. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AK, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERION FOR SUPPRESSED RESULTS BUT THE SAMPLE SIZE WAS TOO LOW (<17) TO ASSESS THE RATE OF POINTS OUTSIDE TOTAL ALLOWABLE ERROR (EA). NO DEFICIENCY HAS BEEN IDENTIFIED.

Description of Event or Problem

NA.