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 03/05/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The serial number of the customer's cobas 4000 c311 stand alone system is (b)(6).The investigation is ongoing.

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
• 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: 18959787
• MDR Text Key: 338445413
• Report Number: 1823260-2024-00869
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (y/n): Y
• Reporter Country Code: AR
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 04810716190
• Device Lot Number: 72593401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/17/2024
• 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