I-STAT CREA CARTRIDGE
Received Mar 17, 2017 · Event occurred Mar 13, 2017
Report 2245578-2017-00011 · MDR key 6412582
Device
Generic name
Crea Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
03P84-25
Lot number
A16339
Product problems
- False Positive Result
- False Positive Result
Patient
67 YR
- Breast Mass
- Breast Mass
Narrative
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 04/19/2017. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.
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 RESULT OF 2.3 ON A (B)(6) FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: (B)(6) 2017, SAMPLE: A, COLLECTED: 11:40, TESTED: 11:53, RESULT: 2.3; (B)(6) 2017, A, 11:40, 12:21, 0.7. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.