MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION; NADH OXIDATION/NAD REDUCTION, AST/SGOT

Catalog Number	08056838190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was(b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable aspartate aminotransferase acc.To ifcc with pyridoxal phosphate activation (astp) results from the cobas c 503 analytical unit.The initial result was 35.8 ui/l with a data flag.The repeat result with an automatic 1:10 dilution was 62.4 ui/l.The repeat results with no dilution were 24.9 ui/l and 25.3 ui/l.The result of 25 uiu/l was believed to be correct.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The calibration and qc data were acceptable.The analyzer alarm trace contained a large number of abnormal aspiration alarms.The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• Brand Name: ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH 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: 20130302
• Report Number: 1823260-2024-02544
• Device Sequence Number: 7417926
• Product Code: CIT
• UDI-Device Identifier: 07613336121023
• UDI-Public: 07613336121023
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 12/23/2024

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 Catalogue Number: 08056838190
• Device Lot Number: 785546
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 12/23/2024
• 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