I-STAT CG8+ CARTRIDGE

MDR report key: 6100060 · Received November 14, 2016

Report

Report Number: 2245578-2016-00109
Event Type: Malfunction
Date Received: November 14, 2016
Date of Event: October 16, 2016
Report Date: December 7, 2016
Manufacturer: ABBOTT POINT OF CARE
Product Code: JGS
PMA / PMN Number: K940918
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 12/06/2016. CUSTOMER RETURNS AND RETAIN PRODUCT WAS TESTED AND THE CUSTOMER COMPLAINT WAS NOT REPRODUCED.

Description of Event or Problem · 1

ON 10/20/2015, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED HEMATOCRIT RESULTS ON AN (B)(6) PATIENT PRESENTED IN THE EMERGENCY ROOM WITH A GI BLEED. THE CUSTOMER STATED THAT THE PATIENT WAS TREATED OFF THE I-STAT RESULT AND WAS TRANSFUSED WITH 1 UNIT OF PACKED RED BLOOD CELLS. THERE WAS NO REPEAT ON I-STAT AND THE CUSTOMER STATES THERE WERE OTHER FACTORS /CLINICAL PICTURE OF THE PATIENT CONTRIBUTING TO THE DECISION FOR THE DOCTOR TO GIVE THE BLOOD TRANSFUSION. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME AND BASED ON THE LIMITED INFORMATION AVAILABLE, APOC DOES NOT SUSPECT A MALFUNCTION EXITS. HOWEVER, THE CUSTOMER STATES THAT THE PATIENT WAS TRANSFUSED BASED ON OFF I-STAT RESULT AND APOC BELIEVES AN ADVERSE EVENT OCCURRED. THE INVESTIGATION IS UNDERWAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
750106	I-STAT CG8+ CARTRIDGE	CG8+ CARTRIDGE	JGS	ABBOTT POINT OF CARE	NA	L16176

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR		Other