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

Catalog Number	03183793122
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial numbers are (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable phosphate (inorganic) ver.2 results from the cobas 8000 cobas c 502 module.Patient 1's initial result on (b)(6) 2025 was 6.8 mg/dl.A repeat result on (b)(6) 2025 was 8.3 mg/dl.Another repeat result after a 1:2 dilution was 3 mg/dl.Patient 2's initial result on (b)(6) 2025 was 8.4 mg/dl.A repeat result on (b)(6) 2025 was 8.5 mg/dl.Another repeat result after a 1:2 dilution was 3.4 mg/dl.The customer is unsure which results are correct.
Additional Manufacturer Narrative
Qc and calibration were passing at the time of the event.The customer determined that the questionable results were due to the patient samples.The investigation determined that there was no product issue.

• 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: 22104310
• Report Number: 1823260-2025-01638
• Device Sequence Number: 15292711
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 06/17/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 03183793122
• Device Lot Number: 83452301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/17/2025
• 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 Sex: Unknown