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

Catalog Number 07559992190

Device Problem Non Reproducible Results (4029)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys folate iii assay results from one patient sample tested on the cobas e411 rack.The initial result was 5.96 nmol/l.The first repeat result was 45.4 nmol/l with a data flag.The second repeat result was 16.79 nmol/l.The third repeat result was 6.73 nmol/l.

Manufacturer Narrative

The serial number of the customer's cobas e411 rack is (b)(6).The investigation is ongoing.

Manufacturer Narrative

The investigation reviewed the last calibration performed on (b)(6) 2023; the results were within specifications.The investigation reviewed the qc data; the qc was within the specified ranges - within specified ranges (within +/-1 standard deviation sd); there was no indication of a general reagent issue.The investigation noted that the field service engineer (fse) inspected the analyzer, cleaned the gripper, and performed a precision check which showed normal analyzer function; the customer has not reported new issues and the fse confirmed that the analyzer is performing well after the service.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS FOLATE III
• Type of Device: ACID, FOLIC, RADIOIMMUNOASSAY
• 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 46250-0457
• MDR Report Key: 18130156
• MDR Text Key: 328032236
• Report Number: 1823260-2023-03596
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): Y
• Reporter Country Code: SI
• PMA/PMN Number: K082340
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07559992190
• Device Lot Number: 72679201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• 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