I-STAT CREA CARTRIDGE
Received Jan 5, 2022 · Event occurred Dec 15, 2021
Report 2245578-2022-00002 · MDR key 13170128
Device
Generic name
Crea+ Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
03P84-25
Lot number
A21239A
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 4.0 MG/DL ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). TEST/COLLECTION TIMES NOT PROVIDED. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. PATIENT MEDICATION WAS REQUESTED AS IT IS SUSPECTED THAT PATIENT MAY BE TAKING HYDROXYUREA. I-STAT RESULTS CAN BE HIGHER THAN NORMAL WITH THE USE OF HYDROXYUREA, A SUBSTANCE THAT IS KNOWN TO INTERFERE WITH THE I-STAT CREATININE ASSAY. REFER TO ART: 714183-00 REV AA. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.
Additional Manufacturer Narrative
APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.
Additional Manufacturer Narrative
APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 10-JAN-2022. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING FOR THE LOT MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
NA.