MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C702
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	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer performed repeatability testing with acceptable results.Frequent "abnormal aspiration" alarms were observed on the alarm trace data between 17-jan-2023 and 19-jan-2023.The photometer lamp and cuvettes were replaced according to product labeling.The customer cleans the sample and reagent probes regularly.All necessary special wash programming has been installed.No non-roche reagents are installed on the instrument.The customer has had no further issues.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for tp2 total protein gen.2 (tp2) on a cobas 8000 c 702 module.The initial result was 1.42 g/l.On (b)(6) 2023 the sample was repeated on a different cobas instrument with a result of 65.4 g/l.This result corresponded to the patient¿s health.The questionable low result was not reported outside of the laboratory.The tp2 reagent lot number was 66367801 with an expiration date of 31-dec-2023.
Additional Manufacturer Narrative
Relevant calibration data from 13-jan-2023 was reviewed and was acceptable.Qc was acceptable.Precision check results were acceptable.A general reagent problem was excluded as calibration and qc were acceptable.Based on the frequent aspiration alarms on the alarm trace data, the investigation determined the event was consistent with a contaminated sample probe due to pre-analytical handling issues.The investigation did not identify a product problem.

• Brand Name: COBAS 8000 C 702 MODULE
• 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: 16312917
• Report Number: 1823260-2023-00381
• Device Sequence Number: 17677790
• Product Code: JJE
• UDI-Device Identifier: 04015630925100
• UDI-Public: 04015630925100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100853
• 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): 03/21/2023

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: C702
• Device Catalogue Number: 06473245001
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/21/2023
• 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