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

Catalog Number	04528778001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and the expiration date were requested but not provided.On the field service engineer's initial service visit, he inspected the analyzer and verified the level detection cable, tube bottom detector, sample probe position, syringe, and seal were working according to specifications.He noted that the cleaner bottle sensor was faulty.In his follow-up service visit, he replaced this part.Emptied and refilled the water bottle, loaded a new cleaner bottle, and reinitialized the analyzer.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable creatinine (creap2) result from one patient sample tested on the cobas c 111 analyzer.On (b)(6) 2025: the initial result of the initial sample was 258.0 umol/l with a data flag.The initial result of a repeat sample was 71.2 umol/l.On (b)(6) 2025: the first repeat result of the initial sample was 76.6 umol/l.The second repeat result of the initial sample was 73.3 umol/l.The repeat result of the repeat sample from another laboratory was 74.6 umol/l.
Additional Manufacturer Narrative
The customer only inverted the patient sample tube thrice and centrifuged it at 2600 g for ten minutes.The investigation determined the customer did not follow the patient sample tube manufacturer's guidelines.The investigation determined the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• 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: 21343320
• Report Number: 1823260-2025-00373
• Device Sequence Number: 7835487
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 03/03/2025

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 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/03/2025
• 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 Age: 43 YR
• Patient Sex: Female