MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FOLATE III; FOLIC ACID ASSAY

Catalog Number 08324131190

Device Problem Low Test Results (2458)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable folate g3 elecsys results from the cobas 8000 - cobas e 602 module when testing the samples with two versions of the reagent.Example 1 initial result with version 2 was 5.98 nmol/l and the repeat result with version 3 was 4.58 nmol/l.Example 2 initial result with version 2 was 30.85 nmol/l and the repeat result with version 3 was 22.48 nmol/l.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

The cobas 8000 - cobas e 602 module serial number was(b)(6).The investigation is ongoing.

Manufacturer Narrative

Medwatch field d4 expiration date was updated.The investigation did not identify a product problem.The cause of the event could not be determined.The customer's calibration and qc data do not suggest a reagent issue.

• Brand Name: ELECSYS FOLATE III
• Type of Device: FOLIC ACID ASSAY
• 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: 18864938
• MDR Text Key: 337312753
• Report Number: 1823260-2024-00705
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: K141426
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08324131190
• Device Lot Number: 726840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• 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