ELECSYS PROBNP II
Received Mar 27, 2025 · Event occurred Mar 13, 2025
Report 1823260-2025-00903 · MDR key 21707229
Device
Generic name
Test,natriuretic Peptide
Manufacturer
Roche DiagnosticsCatalog number
09315268190
Lot number
79975801
Product problems
- Low Test Results
- High Readings
- Low Readings
- Low Test Results
- High Readings
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 8000 - COBAS E 602 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE EVENT WAS CONSISTENT WITH A REAGENT PACK HANDLING ISSUE. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE APPEARED TO BE ISOLATED TO THE SPECIFIC REAGENT PACK AS THE ISSUE WAS RESOLVED BY REPLACING THE REAGENT PACK.
Description of Event or Problem
THERE AS AN ALLEGATION OF QUESTIONABLE ELECSYS PROBNP II RESULTS FROM THE COBAS 8000 - COBAS E 602 MODULE. THE REPEAT RESULTS WERE OBTAINED AFTER THE CUSTOMER REPLACED THE REAGENT PACK WITH A PACK FROM THE SAME LOT. THE INITIAL RESULT FOR ALL OF THE SAMPLES WAS <10 PG/ML. SAMPLE A REPEAT RESULT WAS 434.910 PG/ML. SAMPLE B REPEAT RESULT WAS 35810 PG/ML. SAMPLE 2 REPEAT RESULT WAS 19910.9 PG/ML. SAMPLE 4 REPEAT RESULT WAS 783.4 PG/ML. SAMPLE 7 REPEAT RESULT WAS >35000 PG/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.