I-STAT B-HCG CARTRIDGE

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

ON (B)(6) 2015, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT B-HCG CARTRIDGES THAT YIELDED A SUSPECTED FALSE POSITIVE RESULT ON A (B)(6) FEMALE PATIENT PRESENTED FOR RIGHT UPPER QUADRANT ABDOMINAL PAIN. THE PREGNANCY TEST WAS ADMINISTERED BEFORE PERFORMING X-RAYS. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE PATIENT WAS GIVEN A TRANSVAGINAL ULTRASOUND, WHICH CONFIRMED THE PATIENT WAS NOT PREGNANT. THE PATIENT WAS GIVEN AN APPENDECTOMY AND LATER DISCHARGED. THE CUSTOMER STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: (B)(6) 2016, METHOD: I-STAT, RESULT: 36.5. ON (B)(6) 2016, VISTA, <1. BASED ON THE INFORMATION AVAILABLE AND INTERNAL CONTROL ALGORITHMS THE EVENT IS REPORTABLE AS A POTENTIAL PRODUCT MALFUNCTION ALTHOUGH NOT CONFIRMED AT THIS TIME. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

Additional Manufacturer Narrative

(B)(4). THE INVESTIGATION WAS COMPLETED ON 05/03/2016. CUSTOMER RETURNS AND RETAIN PRODUCT WAS TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

Description of Event or Problem

NA