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

Catalog Number	04528778001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 111 analyzer serial number is (b)(6).The customer performed several maintenance actions to address potential inaccuracies that also happen in quality control, including desproteinization, needle activation, water and waste reservoir cleaning, air/water calibration, and recalibration of quality controls.Despite these actions, the discrepancies persisted.A field service engineer (fse) performed hydraulic system decontamination with warm water.After that, the customer was able to proceed with calibration and control, passing within the specified ranges.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable phosphate ver.2 result from the cobas c 111 analyzer for 1 patient.The initial result was 9.2 mg/dl, and the repeat result was 7.2 mg/dl.At a different laboratory using an unspecified analyzer, the result was 4.3 mg/dl.
Additional Manufacturer Narrative
The medwatch section d, device identification was updated.Relevant fields of sections d and g were updated.The investigation determined that the root cause is most likely related to a contamination issue, which may be caused by a lack of water and waste container maintenance, leading to possible tubing contamination.After the hydraulic system decontamination, no further complaints regarding results discrepancy were reported.

• 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 ; SZ 6343
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 25299413
• Report Number: 1823260-2026-02072
• Device Sequence Number: 15808136
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/24/2026

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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/24/2026
• 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