MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 303 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	09793194001
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	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for tina-quant hemoglobin a1cdx gen.3 (a1cx3) on a cobas c 303 analytical unit.The initial result was 17.5% with a data flag.The doctor questioned this result.The sample was repeated twice, with results of 4.99% and 4.93%.
Additional Manufacturer Narrative
Section d, device identification, was updated.Relevant fields of sections d and g were updated.The a1cx3 reagent lot number was 872465 with an expiration date of 31-aug-2026.Qc was acceptable.There was no indication of a reagent performance issue.No preanalytical issues were identified.There are numerous "water level decrease" alarms on the date of the event.The field service engineer (fse) found a small kink in the vacuum tubing for a nozzle; this kink intermittently inhibited full aspiration during detergent dispense, leading to detergent overflow into other cells.The fse performed all probe and fluidic adjustments, decontaminated the sample and reagent probes, adjusted the gear pump pressure, performed cell blank calibration, and mechanism checks.The vacuum lines were traced from the cell rinse to the vacuum bottle, ensuring the tubing was positioned correctly with no damage or kinks.Precision testing was completed with qc material.The investigation determined that the issue found by the fse (kinked vacuum tubing) was the root cause of the event.

• Brand Name: COBAS C 303 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• 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 46250-0457
• MDR Report Key: 24441846
• Report Number: 1823260-2026-00667
• Device Sequence Number: 13353129
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 09793194001
• Device Lot Number: 872465
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/24/2026
• 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