MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFE GEN.2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	06407137190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 701 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with creatinine jaffe gen.2 on a cobas 8000 c 701 module.The sample initially resulted in a creatinine value of 423 umol/l.A new sample was collected from the patient on (b)(6) 2025 and this sample resulted in a creatinine value of 63.0 umo/l.Both samples were then repeated, with the first sample resulting in a creatinine value of 66.7 umol/l and the second sample resulting in a value of 65.1 umol/l.The first sample was repeated on an unknown third-party platform, resulting in a creatinine value of 60 umol/l.The low values were deemed correct by the customer.
Additional Manufacturer Narrative
A reagent issue can be excluded since quality control values were within specified ranges.The sample clotting time was shorter than recommended by the tube manufacturer.The field service engineer cleaned the incubation chamber, ultrasonic head, reaction cups, and dust cover.No hardware related issues were observed.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• Brand Name: CREATININE JAFFE GEN.2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, 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: 22077784
• Report Number: 1823260-2025-01584
• Device Sequence Number: 21180723
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/25/2025

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: 06/30/2026
• Device Catalogue Number: 06407137190
• Device Lot Number: 82409301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/25/2025
• 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
• Patient Sex: Unknown