MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 703 ANALYTICAL UNIT; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	C703
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calcium gen.2 (ca2) reagent lot number is 894309.The investigation reviewed the data provided by the customer: the calibration and qc results were within the specified ranges; a general reagent issue was not detected.The alarm trace shows many abnormal aspiration and sample-short alarms, indicating pre-analytical or sample-handling issues.It also shows calibration errors, sample probe wash errors, sample pipetter adjustment failure, and abnormal cell blank.The field service engineer inspected the analyzer; cleaned and adjusted the sample probes; replaced the cuvettes, which had gel residues; replaced the ultrasonic station, which had crystallized residues; verified the cuvette wash adjustment; and cleaned the external parts of the reagent probes and the nozzles of the rinse arm.The calibrations and qcs performed after the service were acceptable.The investigation determined that the service actions resolved the issue.The investigation determined that the event was consistent with a combination of instrument issues (misadjustments, contaminations) and preanalytic issues at the customer's site.
Event or Problem Description
The initial reporter received a questionable calcium gen.2 (ca2) assay result for one patient's sample tested on the cobas c 703 analytical unit.The initial result from the analyzer was 4.97 mg/dl or 4.5 mg/dl.The repeat results from a cobas c 702 were 9.10 mg/dl and 9.26 mg/dl.

• Brand Name: COBAS C 703 ANALYTICAL UNIT
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 25487343
• Report Number: 1823260-2026-02330
• Device Sequence Number: 9735511
• Product Code: JJE
• UDI-Device Identifier: 07613336200544
• UDI-Public: 07613336200544
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K253490
• 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): 06/12/2026

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 Model Number: C703
• Device Catalogue Number: 09502971001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/12/2026
• 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 Age: 16 YR
• Patient Sex: Unknown