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

Catalog Number 06407137190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Section e1 facility name continued: reception centr quai de dechargement 2 the investigation is ongoing.

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
• Type of Device: 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
• MDR Text Key: 320349420
• Report Number: 1823260-2023-02509
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 06407137190
• Device Lot Number: 73188101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENALAPRIL
• Patient Age: 9 MO
• Patient Sex: Male