I-STAT CREA CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. THE INVESTIGATION WAS COMPLETED ON 04/10/2017. RETAIN PRODUCT WAS TESTED AND WAS PERFORMING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAIN CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. Z APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. ASSESSMENT: THE RESULTS ON THE I-STAT ARE CONSISTENT ON THE PATIENT. THE COMPLAINT INVESTIGATION CONCLUDED THERE WAS NO PRODUCT DEFICIENCY AND THAT THE I-STAT CARTRIDGE LOT IS MEETING SPECIFICATION. THE PATIENT IS BEING TREATED FOR VOCAL CANCER AND HYDOXYUREA COULD BE USED IN THE TREATMENT. THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHETHER AN I-STAT PRODUCT MALFUNCTION OCCURRED.

Description of Event or Problem

ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREA RESULTS ON A PATIENT WHO WAS REPORTED TO HAVE MANY AILMENTS INCLUDING VOCAL CANCER. NO OTHER PATIENT INFORMATION WAS PROVIDED. (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)(6)).