ELECSYS PROBNP II
Received Mar 30, 2026 · Event occurred Mar 5, 2026
Report 1823260-2026-01136 · MDR key 24716631
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsCatalog number
09315284214
Lot number
878498
Product problems
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PROBNP REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS PURE E 402 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS PROBNP II ASSAY ON A COBAS PURE E 402 ANALYTICAL UNIT. INITIAL RESULT: 21.9 PG/ML. THE INITIAL RESULT DID NOT CORRELATE WITH THE PATIENT'S HISTORY, PROMPTING THE REPEAT OF THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED TO THE PATIENT. 1ST REPEAT RESULT: NO VALUE WAS OBTAINED, AND A "SAMPLE SHORT" ALARM WAS GENERATED. 2ND REPEAT RESULT: 1010 PG/ML. 3RD REPEAT RESULT: 1030 PG/ML.