I-STAT CREA CARTRIDGE
Received Aug 10, 2021 · Event occurred Jul 19, 2021
Report 2245578-2021-00062 · MDR key 12304965
Device
Generic name
Crea+ Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
03P84-25
Lot number
A21144
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
66 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 27-SEP-2021. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE APPLICABLE 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 FOR CREA CARTRIDGE LOT A21144.
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) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT CREATININE RESULTS OF 0.8 AND 0.7 ON AN (B)(6) YEAR OLD FEMALE PATIENT PRESENTED WITH MALIGNANT NEOPLASM. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. (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 LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.