I-STAT B-HCG CARTRIDGE

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 A TRANSVAGINAL ULTRASOUND, WHICH CONFIRMED THE PATIENT WAS NOT PREGNANT. THE CUSTOMER STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE, METHOD, SAMPLE, SAMPLE TIME, RESULT TIME, RESULT: (B)(6) 2016, I-STAT, A , 1505, 1507, >2000; (B)(6) 2016, SIEMENS, A, 1505, 1511, <1; (B)(6) 2016, I-STAT, B, 1714, 1717, >2000; (B)(6) 2016, ALERE, URINE, 1457, 1701, NEGATIVE. 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 05/18/2016. RETAIN PRODUCT WAS TESTED AND IS FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

Description of Event or Problem

NA