MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED; NADH OXIDATION/NAD REDUCTION, AST/SGOT

Model Number	AST
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that the issue is related to the patient sample as the presence of macro ast was detected in the sample after precipitation with polyethylene glycol (peg).There were no follow up actions.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.Discrepant low results were generated by a cobas 6000 c (501) module.The events involved a total of 1 patient with the following: three samples with erroneous results for astl aspartate aminotransferase acc.To ifcc without pyridoxal phosphate activation.

• Brand Name: ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED
• Common Device Name: NADH OXIDATION/NAD REDUCTION, AST/SGOT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8830157
• Report Number: 1823260-2019-90167
• Device Sequence Number: 16772727
• Product Code: CIT
• UDI-Device Identifier: 04015630913855
• UDI-Public: 04015630913855
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: No Information
• Device Model Number: AST
• Device Lot Number: ASKU
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1