MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASPARTATE AMINOTRANSFERASE (AST)(S GOT); ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM

Catalog Number	05850819190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received questionable results for two samples collected from the same patient and tested with astl aspartate aminotransferase acc.To ifcc without pyridoxal phosphate activation on a cobas 8000 c (701) module.The sample values were reported outside of the laboratory.The medication the patient was taking was suspected to interfere with the assay.The first sample initially resulted in an ast value of 285 u/l and repeated as 23 u/l.The 285 u/l value was reported to the patient.Due to a normal alt value, the sample was repeated on (b)(6) 2021, resulting in an ast value of 51 u/l.The 51 u/l value was also reported outside of the laboratory to the patient.The patient stated that the high value of 285 u/l is expected according to her medical situation.The second sample was initially tested twice on (b)(6) 2021, each time resulting in a value of 320 u/l.The sample was repeated again that same day, resulting in a value of 270 u/l.On (b)(6) 2021, the sample was repeated, resulting in a value of around 140 u/l.The serial number of the c701 analyzer is (b)(4).
Additional Manufacturer Narrative
The calibration and qc trace did not indicate an issue.A general system and reagent problem can be excluded because the provided quality validation data were within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ASPARTATE AMINOTRANSFERASE (AST)(S GOT)
• Common Device Name: ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12511668
• Report Number: 1823260-2021-02765
• Device Sequence Number: 3487930
• Product Code: CIT
• UDI-Device Identifier: 04015630928934
• UDI-Public: 04015630928934
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (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): 11/08/2021

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: 08/31/2022
• Device Catalogue Number: 05850819190
• Device Lot Number: 553920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THYROXINE; THYROXINE
• Patient Sex: Female