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

Catalog Number 07559992190

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

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

Event Date 04/19/2022

Event Type  malfunction  

Event Description

The initial reporter complained of questionable results between different lots of elecsys folate iii (folate iii) reagent tested on a cobas 6000 e 601 module.The customer was performing lot to lot comparisons between old reagent lot 536855 and new reagent lot 596881.The folate iii results from the new reagent lot are in question as they are lower than the results from the old reagent lot.The customer noted the calibration signals for the new reagent lot were much lower than the calibration signals on the old reagent lot.Discrepant results were identified for 3 patient samples tested between reagent lot 536855 and reagent lot 596881.Each sample was run 6 times with each reagent lot: patient 1 with lot 596881 showed results between 5.85 ng/ml and 6.90 ng/ml patient 1 with lot 536855 showed results between 6.85 ng/ml and 8.53 ng/ml.Patient 2 with lot 596881 showed results between 13.31 ng/ml and 14.69 ng/ml patient 2 with lot 536855 showed results between 15.61 ng/ml and 17.98 ng/ml.Patient 3 with lot 596881 showed results between 19.48 mg/dl and 22.12 ng/ml patient 3 with lot 536855 showed results between 21.85 mg/dl and 25.67 ng/ml.It is not clear if the comparison data was only being used for lot to lot comparison purposes or if it was being used for diagnostic purposes.No results generated from the comparison testing were reported outside of the laboratory.The e601 module serial number was (b)(4).

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

Section d4, expiration date was updated.Both reagent lots were calibrated on the date of event and the results were acceptable.The qc data provided is within specifications.Preventive maintenance was performed by the field service engineer (fse) on (b)(6)-2022.No issues were identified.Syringe packages and sipper tubes were replaced.Precision data was acceptable.A review of worldwide data of qc recovery for both reagent lots does not show the negative shift the customer observed when they compared patient samples between reagent lots 596881 and 536855.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14435390
• MDR Text Key: 300315207
• Report Number: 1823260-2022-01431
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 07559992190
• Device Lot Number: 596881
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• 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