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	09/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The creaj2 reagent lot number was 71025601 with an expiration date of 30-nov-2024.The last calibration was performed on (b)(6) 2023 with the reagent lot 564944 and the calibration was acceptable.There was only one day of data where the qc was within range.The centrifugation speed was 4000 rounds/minute for 10 minutes.Based on the data, a general reagent issue can be excluded.On (b)(6) 2023 the customer had a low liquid detection (lld) error.The field service engineer checked all lld circuits and found that the electric ground needed to be repaired.He repaired the electric ground.The root cause was consistent with a hardware issue/lld circuits.The service action (repairing the electric ground) resolved the issue.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's plasma sample tested with creatinine jaffé gen.2 (creaj2) assay on a cobas c111 analyzer.Initial result: 3.19 mg/dl.1st repeat result: 0.82 mg/dl (manual).2nd rerun result: 0.53 mg/dl.No questionable result was reported outside the laboratory.The 2nd repeat result of 0.53 mg/dl was 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: 17995560
• Report Number: 1823260-2023-03411
• Device Sequence Number: 6754102
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• 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): 10/24/2023

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 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: 09/30/2023
• Initial Report FDA Received Date: 10/24/2023
• 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