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

Catalog Number	05850819190
Medical Device Problem Codes	Mechanical Problem (1384); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The specific analyzer and serial number used were not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ast results from a cobas 8000 analyzer.The customer alleged the results might not be correct due to a potential interference.The patient had similar results one month ago (no specific data provided) and the customer believes that some substance such as a drug metabolite may be affecting the results.The initial result was 105 u/l with an invalidating data flag.The repeat result with a 1:5 dilution was 101.69 u/l with a data flag.
Additional Manufacturer Narrative
General instrument issues were excluded as only this single incident was reported.There was no allegation of issues with calibration or qc.An interference was found to be unlikely as previous values for the patient were acceptable and the patient was taking the same medication when previous values were generated.The investigation determined the issue was consistent with 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: 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20155974
• Report Number: 1823260-2024-02574
• Device Sequence Number: 18200860
• Product Code: CIT
• UDI-Device Identifier: 04015630928934
• UDI-Public: 04015630928934
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: 05850819190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIPHENHYDRAMINE; URSODEOXYCHOLIC ACID
• Patient Sex: Unknown