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

Catalog Number	05850819190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of 1 patient sample containing an interfering factor that causes a lower ast aspartate aminotransferase acc.To ifcc without pyridoxal phosphate activation result, but the alt alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation result is elevated.The customer suspects the high ureal urea/bun result may be a factor in this result pattern.The patient also tested positive for cocaine and was suspected of tylenol overdose.The following results were from multiple hepatic panels from the same patient: the alt result was 2029 u/l.The ast result was 76 u/l.The bun result was 115 mg/dl.The results were reported outside of the laboratory.The analyzer module and serial number were requested, but not provided.The reagent lot numbers and expiration dates were requested, but not provided.
Additional Manufacturer Narrative
No further information or data was provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: AST
• 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: 14142326
• Report Number: 1823260-2022-01101
• Device Sequence Number: 14449537
• Product Code: CIT
• UDI-Device Identifier: 04015630928934
• UDI-Public: 04015630928934
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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: 05850819190
• Device Lot Number: ASKU
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/06/2022
• 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
• Patient Sex: Unknown