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

Catalog Number	08058610190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable phosphate (inorganic) ver.2 results for 5 patient samples on a cobas c 703 analytical unit.The customer provided an example of discrepant results for 2 patient samples tested.For sample 1, the initial result was 9.5 mg/dl.The repeat result was 5.4 mg/dl.For sample 2, the initial result was approximately 8 mg/dl.The repeat result was 2 mg/dl.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The cobas c 703 analytical unit or a similar device is not cleared or approved for use in the us.The field service engineer found that the sample probes were misaligned/out of adjustment at the wash station.He re-aligned and recalibrated the sample probe washing and drying positions.He also re-aligned the reagent probes (disk a) and verified the correct functioning of other instrument components.The investigation determined that the service actions resolved the issue.

• Brand Name: PHOSPHATE (INORGANIC) VER.2
• Common Device Name: PHOSPHOMOLYBDATE (COLORIMETRIC) - INORGANIC PHOSPHOROUS
• 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: 23512424
• Report Number: 1823260-2025-04571
• Device Sequence Number: 9742261
• Product Code: CEO
• UDI-Device Identifier: 07613336121481
• UDI-Public: 07613336121481
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• 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): 01/06/2026

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: 08058610190
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/06/2026
• 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