I-STAT CREA CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT #: (B)(4). THE INVESTIGATION WAS COMPLETED ON 05/01/2020. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AE (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR CREA LOT A20036.

Additional Manufacturer Narrative

APOC INCIDENT # (B)(6). THE INVESTIGATION WAS COMPLETED ON (B)(6) 2020. THE CUSTOMER REPORTED THAT ANALYZER S/N (B)(6) GENERATED DISCREPANT PATIENT RESULTS WITH CREA CARTRIDGE LOT A20036. ANALYZER S/N (B)(6) WAS INVESTIGATED SEPARATELY UNDER APOC INCIDENT (B)(6) . FAILURE ANALYSIS DID NOT REPRODUCE THE COMPLAINT. THE ANALYZER FUNCTIONED ACCORDING TO SPECIFICATION DURING FAILURE ANALYSIS. A ROCKETWARE SEARCH SPANNING SIX MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

Additional Manufacturer Narrative

APOC INCIDENT # (B)(4). ANALYZER TO BE INVESTIGATED SEPARATELY UNDER APOC INCIDENT # (B)(4). PRODUCT#: 04P75-38, SERIAL#: (B)(4), MFG DATE: 07/22/2016, EXPIRY DATE: N/A. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Description of Event or Problem

ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 0.6MG/DL ON A (B)(6) YEAR OLD FEMALE PATIENT WITH BLOOD IN URINE. THERE WAS ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2020, COLLECTED: 13:30, TESTED: 13:30, RESULT: 2.6MG/DL, SAMPLE: A. I-STAT, (B)(6) 2020, 13:35, 13:35, 0.6MG/DL, A. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. ON (B)(6) 2020 THE CUSTOMER CONTACTED APOC STATING THAT ANALYZER SN (B)(4) BE REPLACED DUE TO THE I-STAT GENERATED DISCREPANT PATIENT RESULTS. ANALYZER SN (B)(4) WILL BE INVESTIGATED SEPARATELY UNDER APOC INCIDENT (B)(4). MEDICATIONS WERE NOT PROVIDED. HOWEVER, THE CUSTOMER CONFIRMED THE PATIENT WAS NOT ON HYDROXYUREA. A SUBSTANCE THAT IS KNOWN TO INTERFERE WITH THE I-STAT CREATININE ASSAY. REFER TO ART: (B)(4) REV AA. 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.