MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	04810716190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable crep2 (creatinine plus ver.2) result from one patient sample tested on the cobas 4000 c311 stand alone system.The initial result was reported outside of the laboratory; a complaint was received prompting the rerun of the patient sample.On (b)(6) 2024: the initial result was 6.32 mg/dl.The first repeat result was 0.59 mg/dl.On (b)(6) 2024: the second repeat result was 0.59 mg/dl.The repeat results were consistent with the patient's clinical condition.
Additional Manufacturer Narrative
The serial number of the customer's cobas 4000 c311 stand alone system is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The field service representative (fsr) investigated the event and the customer's processing of patient samples.The fsr determined the event was consistent with the pre-analytical processing of the patient sample.The investigation determined that based on the fsr's investigation, the event was related to a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• Brand Name: CREJ2
• 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: 18959787
• Report Number: 1823260-2024-00869
• Device Sequence Number: 4579658
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (Y/N): Y
• Initial Reporter Country: AR
• PMA/510(K) Number: K941837
• 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): 04/17/2024

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: 01/31/2025
• Device Catalogue Number: 04810716190
• Device Lot Number: 72593401
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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