ELECSYS SFLT-1
Received Jul 21, 2025 · Event occurred Jun 27, 2025
Report 1823260-2025-02221 · MDR key 22554793
Device
Generic name
Placental Growth Factor (plgf) Ivd, Kit, Chemiluminescent Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
07027818190
Lot number
ASKU
Product problems
- Incorrect Measurement
- Incorrect Measurement
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE SLFT/PLGF RATIO RESULTS FOR TWO PATIENTS FROM THE COBAS E 801 MODULE. THE PHYSICIAN CLAIMED THE RESULTS DID NOT IMPLY THE PATIENTS HAD PRE-ECLAMPSIA WHEN, IN FACT, THEY DID. PATIENT 1: THE INITIAL RATIO WAS 10. REPEAT TESTING TWO WEEKS LATER HAD A RESULT OF 13. PATIENT 2: THE INITIAL RATIO WAS 38. REPEAT TESTING SEVEN DAYS LATER HAD A RESULT OF 175.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.