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

Catalog Number	05171377190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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 analyzer serial number is: (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable phosphate (inorganic) ver.2 results for 1 patient sample on a cobas 8000 c702 module.The customer was prompted to repeat the patient sample as their qc shifted.The customer recalibrated and repeated qc prior to repeating the sample.The initial result was 1.5 mg/dl.The repeat result was 1.0 mg/dl.The repeat result was deemed correct.
Additional Manufacturer Narrative
The customer replaced the reagent pack.The field service engineer (fse) performed precision testing successfully.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 23706931
• Report Number: 1823260-2025-04930
• Device Sequence Number: 10670307
• Product Code: CEO
• UDI-Device Identifier: 04015630925094
• UDI-Public: 04015630925094
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 89812301
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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: 42 YR
• Patient Sex: Male