MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2; 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	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned a high result for 1 patient tested for crej2 creatinine jaffé gen.2 (crej2) on a cobas 8000 c 702 module.The initial result was 4.01 mg/dl.This result was reported outside of the laboratory where the physician requested a re-check.A 2nd sample was obtained and the result was 0.28 mg/dl.This sample was repeated with a 1/5 dilution and the result was 0.28 mg/dl.On 11-jul-2023 the original sample was repeated with a result of [-] 0.32 mg/dl.This sample was repeated with a 1/5 dilution and the result was 0.35 mg/dl.On 12-jul-2023 a 3rd sample was obtained and the result was 0.16 mg/dl.The low results were believed to be correct based on the clinical status of the patient.
Additional Manufacturer Narrative
Section e1 facility name continued: reception centr quai de dechargement 2 the investigation is ongoing.
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).The customer used 13 mm primary sample tubes with no rack adapters.Calibration and qc were acceptable.An abnormal aspiration (sample probe) error was observed on the alarm trace data from the day of the event.The customer did not provide any additional information and sample material is no longer available.A general reagent and hardware issue were excluded as only one crej2 result was in question and no other results were affected.Based on the data available, the investigation determined the event was consistent with a pre-analytical issue.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg)
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 17454801
• Report Number: 1823260-2023-02509
• Device Sequence Number: 7537223
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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): 09/21/2023

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: 02/28/2025
• Device Catalogue Number: 06407137190
• Device Lot Number: 73188101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENALAPRIL
• Patient Age: 9 MO
• Patient Sex: Male