MAUDE Adverse Event Report: ROCHE DIAGNOSTICS PHOS2; 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	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was using phosphorus reagent lot 78223201 (expiration date = 31-may-2025) on 09-sep-2024.The customer started using phosphorus reagent lot number 801953 on 01-oct-2024.The expiration date for this lot number was not provided.The same patient had 3 additional samples tested on both analyzers, resulting in the following values: a sample collected from the patient (sample 2) on (b)(6) 2024 resulted in a phosphorus value of < 0.176 mg/dl with a data flag on (b)(6) 2024.The sample was repeated on a different c 501 analyzer, resulting in a phosphorus value of 0.30 mg/dl on (b)(6) 2024.A second sample collected from the patient (sample 3) on (b)(6) 2024 resulted in a phosphorus value of 0.437 mg/dl on (b)(6) 2024.A third sample collected from the patient (sample 4) on (b)(6) 2024 resulted in a phosphorus value of 0.581 mg/dl on (b)(6) 2024.Medications were administered to the patient prior to each sample collection.The patient has had no health problems due to phosphorus loading.Medwatch field d4 has been updated.
Additional Manufacturer Narrative
The serial number of the c501 analyzer is (b)(6).The serial number of the c 503 analyzer was requested, but not provided.The investigation is ongoing.Medwatch field e1 phone number was provided as (b)(6).
Event or Problem Description
The initial reporter stated they received questionable results for samples from the same patient tested with phos2 (phosphorus) on a cobas 6000 c501 module and a cobas c 503 analytical unit.At least 4 samples from the patient have resulted in phosphorus values of < 0.181 mg/dl accompanied by a data flag when tested on either the c 501 or c 503 systems.The results did not match the patient's clinical diagnosis.Data was provided for one specific sample tested on (b)(6) 2024.This sample initially resulted in a phosphorus value of < 0.181 mg/dl accompanied by a data flag when tested on the c 501 module.This sample was sent to another site where it was tested on a vitros analyzer, resulting in a phosphorus value of 1.1 mg/dl.
Additional Manufacturer Narrative
Calibration and controls were acceptable.Upon review of the alarm trace, 2 abnormal aspiration alarms occurred near the time of the event.Based on analysis of the reaction data, an assay interference is unlikely.The investigation determined that the issue is consistent with physiological alterations to the patient's phosphorus levels based on medications the patient was taking.The patient was taking furosemide, which can cause hypophosphatemia due to increased excretion of phosphorus in the urine.The patient was also taking prednisone which may cause hypophosphatemia by affecting phosphorus metabolism.

• 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: 20348054
• Report Number: 1823260-2024-02841
• Device Sequence Number: 7945542
• Product Code: CEO
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 12/03/2024

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: 10/25/2024
• Device Catalogue Number: 03183793122
• Device Lot Number: 782232, 801953
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 11/19/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/28/2024; 12/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE; DALTEPARIN; DROPERIDOL; ESOMEPRAZOLE; FUROSEMIDE; HALOPERIDOL; INSULINE LANTUS SOLOSTAR; LEVOCETIRIZINE; LOPERAMIDE; LOSARTAN; OLANZAPINE; PARACETAMOL; PREDNISONE; SALMETEROL/FLUTIC; TAMSULOSIN; TRAZODONE; VALPROIC ACID
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 54 KG