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

Catalog Number	06407137190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).A general reagent problem was ruled out because calibration and quality control were acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable creatinine jaffé gen.2 result from the cobas 8000 c702 module.The initial result was 14.74 mg/dl and the repeat result on another cobas analyzer was 6.49 mg/dl.The sample was repeated using ortho and the result was 7.90 mg/dl.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The specific cause of the event could not be determined.Based on the calibration data, the event is consistent with a high concentration of co2 in the ambient air of the laboratory.

• Brand Name: CREATININE JAFFÉ 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19171682
• Report Number: 1823260-2024-01256
• Device Sequence Number: 18129880
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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): 05/03/2024

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: 08/31/2025
• Device Catalogue Number: 06407137190
• Device Lot Number: 766134
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/03/2024
• 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
• Patient Age: 22 YR
• Patient Sex: Female