MAUDE Adverse Event Report: Roche Diagnostics Phosphate (Inorganic) ver.2; Phosphomolybdate (Colorimetric), Inorganic Phosphorus

Catalog Number	05171377190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable phosphate (inorganic) ver.2 results for multiple patient samples on a cobas 8000 cobas c 701 module.The doctor questioned the initial results with prompted the customer to repeat the samples.On (b)(6) 2026, the customer observed multiple patient sample results initially greater than 4 mmol/l, and upon repeat were 1 mmol/l or lower.On (b)(6) 2026, the customer again observed 3 patient sample results initially between 2 and 5 mmol/l, and upon repeat, around 1 mmol/l.The exact patient results were not provided.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) checked the wash stations and gear pump pressure, adjusted the external water volume, verified cuvette washing, and increased the detergent level.The investigation is ongoing.

• Brand Name: Phosphate (Inorganic) ver.2
• Common Device Name: Phosphomolybdate (Colorimetric), Inorganic Phosphorus
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• Manufacturer (Section G): Roche Diagnostics GmbH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 50734305
• Report Number: 1823260-2026-03721
• Device Sequence Number: 16101887
• Product Code: CEO
• UDI-Device Identifier: 04015630925094
• UDI-Public: 04015630925094
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/11/2026

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: 05171377190
• Device Lot Number: 95691101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/11/2026
• 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