MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALTP; ALT/SGPT

Model Number	C303
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of low results for multiple patient samples tested for alanine aminotransferase acc.To ifcc with pyridoxal phosphate activation (altp) on a cobas pure c 303 analytical unit compared to a cobas 8000 system.The following are examples of discrepant results for 4 patient samples.On (b)(6) 2023 patient 1 result from the c303 unit was 12 u/l.The result from the cobas 8000 system was 24 u/l.On (b)(6) 2023 patient 2 result from the c303 unit was 21 u/l.The result from the cobas 8000 system was 38 u/l.On (b)(6) 2023 patient 3 result from the c303 unit was 14 u/l.The result from the cobas 8000 system was 24 u/l.On (b)(6) 2023 patient 4 result from the c303 unit was 12 u/l.The result from the cobas 8000 system was 23 u/l.No questionable results were reported outside of the laboratory.The results from the cobas 8000 system were believed to be correct.The altp reagent lot number was 70466801 with an expiration date of 31-may-2024.
Additional Manufacturer Narrative
The probes are cleaned daily.Precision checks were performed.The investigation is ongoing.H3 other text : na.
Additional Manufacturer Narrative
Calibration and qc data were acceptable.A reagent issue could be excluded.The sample centrifugation speed was faster than recommended by the tube manufacturer.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: ALTP
• Common Device Name: ALT/SGPT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3174767531
• MDR Report Key: 17064739
• Report Number: 1823260-2023-01845
• Device Sequence Number: 11557626
• Product Code: CKA
• UDI-Device Identifier: 07613336120989
• UDI-Public: 07613336120989
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K801119
• 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): 11/30/2023
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2024
• Device Model Number: C303
• Device Catalogue Number: 08056773190
• Device Lot Number: 70466801
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 11/30/2023
• 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