MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASTP; NADH OXIDATION/NAD REDUCTION, AST/SGOT

Catalog Number	08056838190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable astpm aspartate aminotransferase acc.To ifcc with pyridoxal phosphate activation results for 2 patient samples on a cobas pure c 303 analytical unit.For sample 1, the initial ast result was 70.7 u/l.The sample was repeated on a cobas integra analyzer and the repeat result was 45.7 u/l.For sample 2, the initial ast result was 75.0 u/l.The sample was repeated on a cobas integra analyzer and the repeat result was 35.7 u/l.The exact dates of testing for sample 2 were not provided.The cobas integra results were deemed correct.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The root cause of the event was found to be consistent with the comparison of results produced from reagents using pyridoxal phosphate (pyp) activation on the pure c 303 and without pyp activation on the cobas integra.Liver diseases can be associated with pyp deficiency and increased transaminase results which are not properly detected with non activating tests.Per product labeling, "pyridoxal phosphate activation prevents falsely low aminotransferase activity in patient samples with insufficient endogenous pyridoxal phosphate (vitamin b6 deficiency)." the investigation did not identify a product problem.

• Brand Name: ASTP
• Common Device Name: NADH OXIDATION/NAD REDUCTION, AST/SGOT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18798188
• Report Number: 1823260-2024-00580
• Device Sequence Number: 7189416
• Product Code: CIT
• UDI-Device Identifier: 07613336121023
• UDI-Public: 07613336121023
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 05/06/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: 08056838190
• Device Lot Number: 75268601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 05/06/2024
• 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