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

Catalog Number 04810716190

Device Problem Non Reproducible Results (4029)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The alarm trace showed abnormal probe sucking alarms and several water reservoir level too low and bath water sensor alarms.The investigation is ongoing.

Event Description

There was an allegation of questionable crej2 creatinine jaffé gen.2 results for 1 patient sample on a cobas 4000 c (311) stand alone system.The initial crej2 result was 3.07 mg/dl.An aliquot of the sample was repeated and the result was 0.98 mg/dl.On 19-nov-2023, the sample was repeated again and the result was 3.22 mg/dl.The patient's doctor deemed the first repeat result as correct.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

Based on the calibration and qc data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18318672
• MDR Text Key: 330384589
• Report Number: 1823260-2023-03971
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: K941837
• 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: 01/31/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 04810716190
• Device Lot Number: 69958101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1