I-STAT CREA CARTRIDGE
Received Sep 11, 2017 · Event occurred Aug 13, 2017
Report 2245578-2017-00287 · MDR key 6854268
Device
Generic name
Crea Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
03P84-25
Lot number
A17133
Product problems
- False Positive Result
- False Positive Result
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
Description of Event or Problem
ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREA RESULT ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THERE WAS NO REPEAT ON I-STAT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 10/19/2017. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE.