MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05036453001
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	08/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-tshr immunoassay results for 2 patient samples on a cobas 6000 c (501) module.The reporter stated that they did not have the anti-tshr test disabled in the module when the initial daily sample tubes were tested.The reporter questioned the difference in results when the frozen sample tube (specific tube they use for the assay) from the same collection was processed.For sample 1, the initial anti-tshr result was 1.35 iu/l.The repeat result from the frozen sample was 8.88 iu/l.For sample 2, the initial anti-tshr result was 1.12 iu/l.The repeat result from the frozen sample was 7.92 iu/l.The frozen sample result was deemed correct.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Section d product information has been updated, as well as g1 manufacturing site and g4.Calibration was last performed on 20-aug-2024 and the result was acceptable.The qc recovery was acceptable.There was no indication of a performance issue with the reagent.The alarm trace showed multiple sample short and lower reagent volume alarms.The investigation did not identify a product problem.

• Brand Name: COBAS 6000 C (501) 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 46250-0457
• MDR Report Key: 20267086
• Report Number: 1823260-2024-02720
• Device Sequence Number: 11597919
• Product Code: JJE
• UDI-Device Identifier: 07613336160305
• UDI-Public: 07613336160305
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 05036453001
• Device Lot Number: 76925801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/21/2024
• 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 Age: 67 YR
• Patient Sex: Male