ELECSYS PROBNP II
Received Apr 27, 2026
Report 1823260-2026-01638 · MDR key 25002170
Device
Generic name
Natriuretic Peptide Test
Manufacturer
Roche DiagnosticsModel number
PROBNPCatalog number
09744959190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.
Description of Event or Problem
1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM ONE PATIENT TESTED WITH ELECSYS PROBNP II ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: 80 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.