I-STAT CHEM8+ CARTRIDGE
Received Sep 19, 2017 · Event occurred Aug 17, 2017
Report 2245578-2017-00301 · MDR key 6875350
Device
Generic name
Chem8+ Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
09P31-25
Lot number
H17100
Product problems
- False Positive Result
- False Positive Result
Patient
11 YR
- Abdominal Pain
- Abdominal Pain
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 CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT RESULTS ON AN (B)(6) MALE PATIENT WHO WAS TESTED FOR POSSIBLE BLOOD LOSS; BLOOD IN STOOL FOR DAYS. THERE WAS NO ADDITIONAL PATIENT INFORMATION. THE PATIENT WAS ADMITTED ON (B)(6) 2017 AT 19:10 AND DISCHARGED AT 23:18. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THIS REPORTING IS BASED ON LIMITED INFORMATION AVAILABLE. THE INVESTIGATION IS UNDERWAY.
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 10/04/2017. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE.