MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number	C503
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable altlp alanine aminotransferase acc.To ifcc with pyridoxal phosphate activation results for 1 patient sample on a cobas pro c 503 analytical unit.On (b)(6) 2022, the first sample's initial altlp result was 272 u/l.The result was reported outside of the laboratory.A 1:2 dilution was made from the sample and the result was 582 u/l.On (b)(6) 2022, a third 1:2 dilution was made from the first sample.The altlp result was 1150 u/l.A 1:5 dilution was made from the first sample and the result was 970 u/l.A 1:10 dilution was made from the first sample and the result was 842 u/l.A second sample was collected.The altp result was 508 u/l.A 1:2 dilution was made using the second sample and the altlp result was 852 u/l.On (b)(6) 2022, the first sample was tested again and the result was 921 u/l.The reagent lot number is 66105201.The expiration date was requested but not provided.
Additional Manufacturer Narrative
The alarm trace from (b)(6) 2022 was inconspicuous.No further data was provided for the investigation.A general reagent issue was excluded.The investigation determined the event was consistent with a pre-analytical sample handling issue.The investigation did not identify a product problem.The specific cause of the event could not be determined.
Additional Manufacturer Narrative
Sections a2, a3, and b7 have been updated.

• Brand Name: COBAS C 503 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16141306
• Report Number: 1823260-2023-00111
• Device Sequence Number: 20461010
• Product Code: JJE
• UDI-Device Identifier: 07613336120989
• UDI-Public: 07613336120989
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2023

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 Model Number: C503
• Device Catalogue Number: 08463662001
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 01/16/2023; 06/28/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 02/08/2023; 07/19/2023
• 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 Age: 22 YR
• Patient Sex: Male