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

Model Number	C503
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial result's reaction monitor showed a conspicuous reaction, especially at the plateau phase of the reaction.The repeat result's reaction monitor was inconspicuous.The alarm trace provided from (b)(6) 2022 to (b)(6) 2022 showed multiple "abnormal aspiration", "sample foam detected" & "sample clot detection" errors on the date of the event.The precision check was within specifications.The investigation determined that the gear pump's pressure was out of specification.Product labeling states "this will adjust the gp to 320 kpa." the investigation determined that the customer installed a non-roche reagent.Product labeling states "warning! incorrect results due to use of closed development channel applications - the use of non-roche tests involves specific risks: errors during setup lead to systematically incorrect results.The interaction between the reagents and the cobas c pack green is unknown.The stability and onboard stability of the reagents is unknown.Errors during filling the cobas c pack green can damage the instrument and lead to incorrect pipetting." a general reagent problem was ruled out because the qcs were acceptable.The investigation determined that the issue was consistent with the inadequate gear pump pressure, the customer's use of non-roche supported reagents which may have caused unknown carry-over interference, and the multiple abnormal aspirations, sample foam detected & sample clot detection errors on the date of the event.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable total protein result for one patient sample tested on the cobas pro c 503 analytical unit.The initial result was reported outside of the laboratory.On (b)(6) 2022, the initial result was 97.4 g/l.On (b)(6) 2022, the repeat result was 57.3 g/l.The reagent lot number is 59947001.The expiration date is 31-mar-2023.
Additional Manufacturer Narrative
Based on the information provided, the cause of the event could not be determined.

• 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: 15844240
• Report Number: 1823260-2022-03729
• Device Sequence Number: 17638050
• Product Code: JJE
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 04/10/2023

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: 10/25/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 04/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REFER TO THE ATTACHMENT IN THE MEDWATCH
• Patient Age: 57 YR
• Patient Sex: Male