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

Catalog Number	03183793122
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 4000 c311 stand alone system is (b)(6).The field service engineer (fse) inspected the analyzer and determined that the sample probe had to be replaced and a special wash had to be installed.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable phos2 phosphate (inorganic) ver.2 results from an unspecified number of patient samples tested on the cobas 4000 c311 stand alone system.The reporter stated that there were no issues with the phosphate assay if it was run separately.However, when it was run with other assays, the results would be questionable and high.The field service representative (fsr) instructed the customer to change the cells and lamp and perform calibration and qc.The issue was not resolved.It was determined that the wash reaction part and weekly maintenance were not performed.The tasks were performed and the qc was acceptable.However, the issue with the patient results persisted.The reporter was able to provide one example of discrepant results: the initial result was 4.11 mmol/l.The repeat result was 1.03 mmol/l.
Additional Manufacturer Narrative
The customer did not perform the wash reaction part and a special wash had to be implemented.Product labeling states "phos2 action required special wash programming: the use of special wash steps is mandatory when certain test combinations are run together on cobas integra analyzers.Refer to the clean method sheet for further instructions and for the latest version of the extra wash cycle list.Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test." the customer did not perform weekly maintenance.Product labeling states: "weekly maintenance perform these maintenance tasks at least once a week.In this section: cleaning the cell covers, cleaning the rinse stations, washing the reaction parts." the investigation reviewed the calibration data; the results were within specifications.The investigation noted that the results were imprecise; the results were often outside the specification of +/-3 standard deviation (sd).The field service engineer (fse) stated that the event was caused by the sample probe that had to be replaced.Product labeling states "replacing the sample probe if the sample probe is bent or otherwise damaged, you must replace it." the investigation determined the event was consistent with a preanalytic issue at the customer site (the sample probe had to be replaced).Preanalytics are within the customer's responsibility.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
• MDR Report Key: 17798238
• Report Number: 1823260-2023-03059
• Device Sequence Number: 14940830
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (Y/N): Y
• Initial Reporter Country: MU
• 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): 10/20/2023

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: 04/30/2024
• Device Catalogue Number: 03183793122
• Device Lot Number: 70617701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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