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

Model Number	C503
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient samples tested for either hdl-cholesterol gen.4 (hdlc4) or cholesterol gen.2 (chol2) on a cobas pro c 503 analytical unit.Patient 1 initial hdlc4 result was 4.14 mg/dl.The repeat result was 63.6 mg/dl.On (b)(6) 2023 patient 2 initial chol2 result was 8.47 mg/dl.The repeat result was 195 mg/dl.No questionable results were reported outside of the laboratory.The hdlc4 reagent lot number was 63877001 with an expiration date of 30-apr-2024.The chol2 reagent lot number was 640736 with an expiration date of 28-feb-2023.
Additional Manufacturer Narrative
The field service engineer (fse) replaced and adjusted the sample probe.The customer has had no further issues.During a review of the reaction monitor data, there was an abnormal reaction for the initial results.The repeat results showed a normal reaction.Calibration data provided for hdlc4 between (b)(6) 2022 and (b)(6) 2023 was acceptable.Calibration data provided for chol2 between (b)(6) 2022 and (b)(6) 2023 was acceptable.Qc for both assays was acceptable.No issues were identified during a review of the alarm trace data.No foam, fibrin, clots, or strands were observed in the patient samples.A general reagent problem has been ruled out as calibration and qc were acceptable for the affected assays.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the service actions resolved the issue.The issue is consistent with incorrect pre-analytic sample handling.

• 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: 16250269
• Report Number: 1823260-2023-00250
• Device Sequence Number: 20434636
• Product Code: JJE
• UDI-Device Identifier: 07613336121542
• UDI-Public: 07613336121542
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/17/2023

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: 01/09/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/17/2023
• 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