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

Catalog Number	05168589190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatinine plus ver.2 (crep) results for 1 patient sample on a cobas 8000 c702 module.An interference with the creatinine plus ver.2 assay was suspected.The initial result was 97 umol/l.The physician questioned the result because it didn't match the patient's clinical condition.The sample was repeated on an au analyzer (beckman coulter), and the results were 201 umol/l and 197 umol/l.These results were believed to be correct.The sample was repeated on another cobas 8000 c702 module, and the result was 93 umol/l.On (b)(6) 2025, the sample was repeated on the same cobas 8000 c702 module as the initial result.The crep assay result was 94 umol/l, and the cre-j assay result was 212 umol/l.The sample was repeated with the crep assay on a cobas c503 module, and the result was 96.1 umol/l.The creatinine assay used on the cobas 8000 c702 module was crep (enzymatic assay), while the assay used on the au analyzer was cre-j.
Additional Manufacturer Narrative
The qc was acceptable.A general product problem was excluded.The sample was returned for investigation.During cross-platform testing, the enzymatic method consistently yielded falsely low results on all systems (cobas c 702, c 503, and au5800), whereas the jaffé method provided clinically accurate measurements.The investigation concluded that the root cause is an analytical interference caused by an exogenous substance (most likely a medication or supplement) that specifically inhibits the enzymatic reaction.The specific interfering agent could not be isolated due to a lack of a detailed patient medication history.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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23684655
• Report Number: 1823260-2025-04901
• Device Sequence Number: 9761686
• 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): 01/30/2026

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: 04/30/2026
• Device Catalogue Number: 05168589190
• Device Lot Number: 88924701
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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: TACROLIMUS.
• Patient Sex: Female
• Patient Race: Asian