FDA Adverse Event Malfunction Summary report: N

I-STAT CHEM8+ CARTRIDGE

MDR report key: 7050438 · Received November 21, 2017

Report

Report Number: 2245578-2017-00609
Event Type: Malfunction
Date Received: November 21, 2017
Date of Event: October 26, 2017
Report Date: February 2, 2018
Manufacturer: ABBOTT POINT OF CARE
Product Code: JGS
UDI-DI: 10054749001917
PMA / PMN Number: K053110
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL LOT INFORMATION FOR CREA: LOT A17177, MANUFACTURED 06/26/2017, EXPIRES 12/14/2017, (B)(4), K973292. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

Additional Manufacturer Narrative · 1

(B)(4). THE INVESTIGATION WAS COMPLETED ON 02/01/2018. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE.

Description of Event or Problem · 1

ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT ON A (B)(6) FEMALE. THE CUSTOMER ALSO STATES THAT CREA RESULT DOES NOT MATCH THE LAB RESULT. A RESULT WAS PROVIDED FOR THE CREA CARTRIDGE. HOWEVER, THERE WAS NO CREA RESULT PROVIDED FOR THE CHEM8+ CARTRIDGE. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). SAMPLES WERE COLLECTED AND TESTED ON (B)(6) 2017 THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

Description of Event or Problem · 1

NA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
828670	I-STAT CHEM8+ CARTRIDGE	CHEM8+ CARTRIDGE	JGS	ABBOTT POINT OF CARE	NA	H17154	10054749001917

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR