MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION; NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Catalog Number	05850797190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested with alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation on a cobas 8000 c 701 module.All questioned samples had initial alt values < 5 u/l.The samples were repeated on other analyzers after re-centrifugation and the results were slightly higher.The customer provided one example of a patient sample with discrepant alt results.The customer indicated the sample was hemolyzed.The sample initially resulted in an alt value of 5 u/l.The sample was recentrifuged and repeated twice on a second analyzer, resulting in alt values of 24.6 u/l and 24.6 u/l.The sample was repeated on a third analyzer, resulting in a value of 24.3 u/l.The sample was also repeated on a siemens instrument, resulting in an alt value of 30.62 u/l.
Additional Manufacturer Narrative
The serial number of the c 701 analyzer is (b)(6).Calibration and control data were acceptable.A general reagent issue can be ruled out.Upon review of the alarm trace, abnormal aspiration alarms and sample short alarms were observed.The sample centrifugation time was shorter than recommended by the tube manufacturer.It was observed that the customer had lipemic samples, low-volume samples, icteric samples, samples with gel particles detached from the walls, samples with fibrin, and hemolyzed samples.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with inadequate pre-analytic sample handling.

• Brand Name: ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION
• Common Device Name: NADH OXIDATION/NAD REDUCTION, ALT/SGPT
• 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: 20598840
• Report Number: 1823260-2024-03171
• Device Sequence Number: 8796663
• Product Code: CKA
• UDI-Device Identifier: 04015630928927
• UDI-Public: 04015630928927
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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): 11/18/2024

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: 05850797190
• Device Lot Number: 750238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/18/2024
• 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
• Patient Sex: Unknown