MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASTP; NADH OXIDATION/NAD REDUCTION, AST/SGOT

Catalog Number	08056838190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).The customer noted that the assay used with the c503 analyzer uses pyridoxal phosphate (pyp) activation whereas the assay used with the dxc 700 au analyzer does not.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for aspartate aminotransferase acc.To ifcc with pyridoxal phosphate activation (astp) on a cobas pro c 503 analytical unit compared to a dxc 700 au analyzer.The result from the c503 analyzer was 385 u/l.The result from a dxc 700 au analyzer was 181.99 u/l.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
Calibration and qc were acceptable, therefore, a general reagent or instrument issue is not suspected.The investigation determined the event was consistent with two different tests (one with pyridoxal phosphate (pyp) activation and one without pyp) being used to test the patient sample.Assays with pyp show higher results compared to assays without pyp.The investigation did not identify a product problem.

• Brand Name: ASTP
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17250596
• Report Number: 1823260-2023-02160
• Device Sequence Number: 14661172
• Product Code: CIT
• UDI-Device Identifier: 07613336121023
• UDI-Public: 07613336121023
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 07/24/2023

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: 03/31/2024
• Device Catalogue Number: 08056838190
• Device Lot Number: 70098801
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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