I-STAT CREA CARTRIDGE
Received Feb 8, 2023 · Event occurred Jan 27, 2023
Report 2245578-2023-00017 · MDR key 16325907
Device
Generic name
Crea+ Cartridge
Manufacturer
Abbott Point Of CareModel number
NACatalog number
03P84-25
Lot number
A22259
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
75 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 02-FEB-2023, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A 75 YEAR OLD FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DRAWN: 15:05, RESULT: 2.6 MG/DL, SAMPLE: WB; I-STAT, 15:24, 2.4 MG/DL, WB; ROCHE COBAS, 16:03, 1.8 MG/DL, PLASMA. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. 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 01-MAR-2023. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AK, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED.
Description of Event or Problem
NA.