MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PHOS2; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS

Catalog Number	05171377190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The phos2 reagent lot number was 82370701 with an expiration date of 31-dec-2025.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for phosphorus (phos2) on a cobas 8000 c 702 module.The initial result was 0.00 mg/dl.The operator requested repeat testing.The repeat result was 3.79 mg/dl.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The c702 module serial number was (b)(6).Calibration and qc were acceptable.The field service engineer (fse) performed a complete instrument check and no issues were identified.The customer has had no further issues.A general reagent issue is unlikely as calibration and qc were acceptable.The specific cause of the event could not be determined; however, the questionable result received (0.00 mg/dl) suggests the event was consistent with a pre-analytic issue.The investigation did not identify a product problem.

• Brand Name: PHOS2
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 20979472
• Report Number: 1823260-2024-03752
• Device Sequence Number: 15568926
• Product Code: CEO
• UDI-Device Identifier: 04015630925094
• UDI-Public: 04015630925094
• 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,Followup
• Report Date (Section B): 01/06/2025

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: 05171377190
• Device Lot Number: 82370701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/06/2025
• 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