I-STAT CREA CARTRIDGE
Received Mar 8, 2018 · Event occurred Feb 16, 2018
Report 2245578-2018-00108 · MDR key 7325134
Device
Generic name
Crea Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
03P84-25
Lot number
A18010
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
67 YR
- 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) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT ON A (B)(6) YEAR OLD PATIENT WITH AMS (UNK). THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 03/15/2018. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AC, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED.