AMMONIA II
Received Mar 4, 2025 · Event occurred Jan 22, 2025
Report 1823260-2025-00616 · MDR key 21514704
Device
Generic name
Enzymatic Method, Ammonia
Manufacturer
Roche DiagnosticsCatalog number
07236450190
Lot number
ASKU
Product problems
- Incorrect Measurement
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
- Incorrect Measurement
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE NH3L2 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 7 PATIENTS' SAMPLES TESTED WITH AMMONIA II (NH3L2) ASSAY ON A COBAS 8000 C702 MODULE WHEN COMPARED TO A COMPETITOR'S ANALYZER. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 51 UMOL/L. REPEAT RESULT: 118 UMOL/L (TESTED ON ABBOTT NEAT). SAMPLE 2 (PATIENT 2) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 38 UMOL/L. REPEAT RESULT: 167 UMOL/L (TESTED ON ABBOTT NEAT). SAMPLE 3 (PATIENT 3) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 39 UMOL/L. REPEAT RESULT: 107 UMOL/L (THE SAMPLE WAS HAEMOLYSED AND TESTED ON ABBOTT NEAT). SAMPLE 4 (PATIENT 4) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 34 UMOL/L. REPEAT RESULT: 108 UMOL/L (TESTED ON ABBOTT NEAT). SAMPLE 5 (PATIENT 5) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 51 UMOL/L. REPEAT RESULT: 241 UMOL/L (TESTED ON ABBOTT NEAT). SAMPLE 6 (PATIENT 6) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 57 UMOL/L. REPEAT RESULT: 324 UMOL/L (TESTED ON ABBOTT NEAT). SAMPLE 7 (PATIENT 7) WAS TESTED ON (B)(6) 2025: INITIAL RESULT: 60 UMOL/L. REPEATED RESULT: 311 UMOL/L (THE SAMPLE WAS LIPAEMIC AND TESTED ON ABBOTT NEAT).
Additional Manufacturer Narrative
THE DATA WAS REQUESTED FOR THE INVESTIGATION, BUT WAS NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.