MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number	05168589190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's samples tested with creatinine plus ver.2 (crep2) assay on a cobas 8000 c702 module when compared to a cobas c501 module and architect system.Sample 1 was initially tested on c501 resulting in values of 325 umol/l and 336 umol/l.Sample 1 was repeated using a dilution factor of 1:50 on the c501 and the result was 355 umol/l (accompanied by a data flag).The physician questioned the result of 325 umol/l as it did not correlate with the patient's clinical picture and requested a 2nd sample (sample 2) to be drawn.Sample 2 was tested on the c501 resulting in values of 34 umol/l and 35 umol/l.Sample 1 was then repeated resulting in values of: 24 umol/l and 27 umol/l when tested on c702.411.2 umol/l when tested on architect.Sample 2 was also repeated on c702 and architect resulting in values around 35 umol/l to 40 umol/l.
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
A reagent/instrument issue can be excluded because the result was repeatable on c501 and c702 while comparing the same method.The patient was diagnosed with lymphoma.The investigation determined the event was consistent with the patient sample or the patient's medical condition.The product labeling states: "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.

• Brand Name: CREATININE PLUS VER.2
• Common Device Name: ENZYMATIC METHOD, CREATININE
• 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: 21912952
• Report Number: 1823260-2025-01287
• Device Sequence Number: 17919482
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 08/11/2025

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: 08/31/2025
• Device Catalogue Number: 05168589190
• Device Lot Number: 84198201
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 08/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CEPHALOSPORINS (AFTER THE SAMPLE 1 COLLECTION)
• Patient Sex: Unknown