MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 111 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04528778001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gluc2 reagent lot number was 75603501 with an expiration date of 30-apr-2025.A general reagent issue can be excluded since calibration and qc data were acceptable on the day of the event.The field service engineer found dirt and black spots in the external water container.He cleaned the water container.The service actions (cleaning the water container) resolved the issue.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with glucose hk (gluc2) assay on a cobas c111 analyzer.Sample 1: initial result: 188.89 mg/dl.1st repeat result: 95.53 mg/dl.2nd repeat result: 95.57 mg/dl.Sample 2: initial result: 199.05 mg/dl.1st repeat result: 92.42 mg/dl.2nd repeat result: 91.61 mg/dl.The customer questioned the initial results as they did not match the patients' clinical conditions.No questionable results were reported outside the laboratory and the samples were repeated.The repeat results were deemed to be correct.

• Brand Name: COBAS C 111 ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19276769
• Report Number: 1823260-2024-01393
• Device Sequence Number: 7577546
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K063744
• 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
• Report Date (Section B): 05/09/2024

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: 04528778001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/09/2024
• 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