MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PHOSPHATE (INORGANIC) VER.2; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS

Catalog Number	03183793122
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 4000 c311 stand-alone system serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable phosphate (inorganic) ver.2 results from the cobas 4000 c311 standalone system.An interference was suspected.The initial result was 9.80 mg/dl with a data flag.Since the value was particularly high and there were no clinical conditions compatible with renal failure or such a degree of hyperphosphatemia, the test was repeated using a new sample.The elevated value was confirmed at 8.10 mg/dl with a data flag.This led to the hypothesis of interference and the collection of a new sample.The following morning (b)(6) 2025), a third sample was taken from the patient, yielding a result of 8.55 mg/dl with a data flag.The sample was sent to a second laboratory using the same method on a c311 analyzer.The result was 5.7 mg/dl.The sample was also tested in another laboratory, with a result of 3.40 mg/dl.After preventive maintenance was performed and the instrument checked, the samples were repeated, and the results were the same elevated values.No specific data was provided.

• Brand Name: PHOSPHATE (INORGANIC) VER.2
• Common Device Name: PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 23714994
• Report Number: 1823260-2025-04942
• Device Sequence Number: 10275142
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K951595
• 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): 12/04/2025

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: 03183793122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/04/2025
• 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: 88 YR
• Patient Sex: Female