I-STAT B-HCG CARTRIDGE

Additional Manufacturer Narrative

APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 06/02/2016. RETAIN PRODUCT WAS TESTED AND IS FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

Description of Event or Problem

NA

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

ON (B)(6) 2016, 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) PATIENT WITH ABDOMINAL PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE PATIENT WAS GIVEN AN ULTRASOUND, WHICH CONFIRMED THE PATIENT WAS NOT PREGNANT. DATE METHOD B-HCG DATE: (B)(6) 2016, METHOD: I-STAT, B-HCG: 42.8. ON (B)(6) 2016, VISTA, <1.0. 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.