MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04745868001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 core unit 150 (jp vers.) serial number is (b)(6).The field service engineer reviewed all the results and noted that the repeat results were consistent with the initial results.He verified the calibration results.Further testing was performed with successful results.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable tina-quant lipoprotein (a) gen.2 (lpa2) assay results from two patient samples tested on the cobas 6000 core unit 150 (jp vers.).Sample 1 the initial result was 285.30 nmol/l with an invalidating data flag.The first repeat result in decreased mode was 175.81 nmol/l.The second repeat result with the patient sample at manual 2-fold dilution was 71.57 nmol/l with a final computed result of 143.14 nmol/l.The third repeat result in the original mode was 229.74 nmol/l.Sample 2 the initial result was 249.26 nmol/l with an invalidating data flag.The first repeat result in decreased mode was 140.22 nmol/l.The second repeat result with the patient sample at manual 2-fold dilution was 68.22 nmol/l with a final computed result of 136.44 nmol/l.The third repeat result in the original mode was 181.24 nmol/l.The questionable results were not reported outside the laboratory as they did not match the patients' clinical diagnoses.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) updated.The investigation determined the event was consistent with a maintenance issue.The specific cause of the event could not be determined.

• Brand Name: COBAS 6000 CORE 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21399252
• Report Number: 1823260-2025-00460
• Device Sequence Number: 20886687
• Product Code: JJE
• UDI-Device Identifier: 04015630924691
• UDI-Public: 04015630924691
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 12/31/2025
• Device Catalogue Number: 04745868001
• Device Lot Number: 80828501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/24/2025
• 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