MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS CREATININE PLUS VER.2 ASSAY; CREATININE TEST SYSTEM

Catalog Number	08057524190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas pure c 303 analytical unit is (b)(6) the investigation is ongoing.
Event or Problem Description
The initial reporter received questionable creatinine (creap2) results from one patient sample tested on the cobas pure c 303 analytical unit.The initial result was 29.40 umol/l.The repeat result was 28.80 umol/l.The reporter stated that the results were lower than the normal values and could not explained by the patient's medical condition.The physician suspects an interference.
Additional Manufacturer Narrative
The investigation excluded a hardware issue because the results were repeatable.The investigation excluded a reagent issue because the calibration and qc were acceptable.The investigation excluded an interference in the patient sample because the patient was not taking any medication.The investigation determined the event was due to increased clearance of urea, creatinine, and uric acid which may occur during pregnancy due to an increased glomerular filtration rate.The investigation did not identify a product problem.

• Brand Name: COBAS CREATININE PLUS VER.2 ASSAY
• Common Device Name: CREATININE TEST SYSTEM
• 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: 20212012
• Report Number: 1823260-2024-02652
• Device Sequence Number: 7745592
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K024098
• 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): 10/11/2024

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 Catalogue Number: 08057524190
• Device Lot Number: 809600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/11/2024
• 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
• Patient Age: 33 YR
• Patient Sex: Female