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 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e602 analyzer is (b)(6).Calibration signals recovered within expectations.Controls recovered acceptably.The investigation is ongoing.

Event Description

The initial reporter stated they received a questionable result for one patient sample tested with elecsys folate iii on a cobas e 602 module in comparison to the result measured using a previous version/lot of the folate assay.The sample initially resulted in a folate value of 6.83 ug/l when tested using folate reagent lot 726792.The customer repeated the patient sample as part of comparison studies for the new folate reagent, lot 726840.The repeat result with the new lot was 5.06 ug/l.

Manufacturer Narrative

The customer's calibration and control data did not suggest a local or general reagent issue with either of the assay versions/lots.The customer's qc recovery is comparable to their peers.Internal method comparison data, as well as data from standardization, do not suggest a systemic bias between the assay versions.The investigation did not identify a product issue.The cause of the event could not be determined.

• 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: 18904841
• MDR Text Key: 337742881
• Report Number: 1823260-2024-00763
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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: 05/22/2024

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: 08324131190
• Device Lot Number: 726840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/22/2024
• 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