MAUDE Adverse Event Report: Roche Diagnostics Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation; nadh oxidation/nad reduction, alt/sgpt

Catalog Number	04467388190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).It was found that the customer inverts patient samples 2-3 times after collection, allows samples to clot for 15-20 minutes, and centrifuges them at 2739 g.The manufacturer recommends 5-6 inversions, 30 minutes for clotting, and centrifugation at 1800-2200 g.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 and altp results for 4 patient samples on a cobas 4000 c311 stand alone system.This medwatch will cover alt.Refer to medwatch with a1 patient identifier (b)(6) for information on the creatinine results.On (b)(6) 2026, sample 1 had an initial creatinine result of 2.27 mg/dl.The customer questioned the result as it did not match the patient's clinical history which prompted them to repeat the sample.The repeat result was 0.82 mg/dl.No questionable results were reported outside of the laboratory.On (b)(6) 2026, sample 2 had an initial creatinine result of 7.41 mg/dl.The repeat result was 0.56 mg/dl.On (b)(6) 2026, sample 3 had an initial creatinine result of 3.21 mg/dl.The repeat result was 1.03 mg/dl.On (b)(6) 2026, sample 4 had an initial alt result of 584.1 u/l.The repeat result was 19.4 u/l.

• Brand Name: Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation
• Common Device Name: nadh oxidation/nad reduction, alt/sgpt
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• Manufacturer (Section G): Roche Diagnostics GmbH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250--045
• MDR Report Key: 50199917
• Report Number: 1823260-2026-03254
• Device Sequence Number: 13371111
• Product Code: CKA
• UDI-Device Identifier: 04015630920532
• UDI-Public: 04015630920532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: k954992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04467388190
• Device Lot Number: 89425901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown