MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION; NADH OXIDATION/NAD REDUCTION, AST/SGOT

Catalog Number	20764949322
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 502 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with aspartate aminotransferase acc.To ifcc without pyridoxal phosphate activation (ast) on a cobas 8000 c 502 module.The sample initially resulted in an ast value of 93.9 u/l.The patient questioned the result, so the sample was repeated.The sample was repeated on (b)(6) 2024, resulting in an ast value of 20.6 u/l.A second tube collected at the same time was also repeated on a second analyzer on (b)(6) 2024, resulting in a value of 19.9 u/l.
Additional Manufacturer Narrative
Calibration and control data were acceptable.A general reagent issue can be excluded.Upon review of the alarm trace for 09-dec-2024, 12 sample foam detection alarms and one sample clot detection alarm were observed.The investigation could not identify a product problem.The issue is consistent with insufficient pre-analytic sample handling.

• Brand Name: ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION
• 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: 21038996
• Report Number: 1823260-2024-03844
• Device Sequence Number: 12891963
• Product Code: CIT
• UDI-Device Identifier: 04015630913855
• UDI-Public: 04015630913855
• Combination Product (Y/N): N
• 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): 01/21/2025

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: 08/31/2025
• Device Catalogue Number: 20764949322
• Device Lot Number: 80294301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/21/2025
• 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