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

Catalog Number	06473245001
Medical Device Problem Codes	False Positive Result (1227); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 74213801 with an expiration date of 30-apr-2025.The field service representative replaced "sv30" and "sv31" parts, the wash station tubes, sample and reagent probes, and mixers.He performed precision checks with acceptable results.Qc results were acceptable after service.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable crej2 results for approximately 200 patient samples on a cobas 8000 c 702 module.Two examples were provided.Sample 1: the initial result was 0.82 mg/dl.The repeated result was 1.02 mg/dl.This result was believed to be correct.Sample 2: the initial result was 0.74 mg/dl.The repeated result was 0.95 mg/dl.The repeated results were obtained on another c702 module in the same laboratory.The questionable results were reported outside of the laboratory.Amended reports with the correct results were sent.
Additional Manufacturer Narrative
The investigation determined the issue to be consistent with environmental condition issues.The laboratory has a higher co2 concentration (600 to 1000ppm).The laboratory uses a lot of dry ice.System specific issues were excluded.

• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18697126
• Report Number: 1823260-2024-00420
• Device Sequence Number: 17943271
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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 Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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