MalfunctionCGL
ABBOTT ISTAT
Received Jun 24, 2020 · Event occurred Jun 15, 2020
Report MW5095213 · MDR key 10194846
Device
Generic name
Electrode, Ion Based, Enzymatic, Creatinine
Manufacturer
Abbott Point Of Care Canada LimitedModel number
ISTAT 1Catalog number
NA
Lot number
A20061
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Defective Component
Patient
68 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
POC ISTAT RESULTS WERE INCORRECT. HIGHLY DEFECTIVE CR 5.1. RESULTS INDICATED SEVERE RENAL ISSUES. PT HAD NO PRIOR HISTORY OF RENAL IMPAIRMENT. COMPLETED MRI W/O CONTRAST DUE TO THIS RESULT. PT WENT TO (B)(6) ED FOR EVALUATION. LABS DRAWN THERE INDICATED NORMAL RENAL FUNCTION 0.9 CR. CONCERN FOR DEFECTIVE CARTRIDGE. DEVICE HAS FUNCTIONED W/O ISSUE SINCE EVENT. THE PT AND HER PHYSICIAN WERE MADE AWARE OF THIS ERROR.