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

Model Number	FOLATE G3
Medical Device Problem Codes	Failure to Recalibrate (1517); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Calibrate (2440); High Test Results (2457); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys folate iii assay results for 8 patient samples on a cobas e 801 module.The initial results were reported outside of the laboratory.The customer was prompted to repeat the samples as they were having calibration and qc issues.For patient 1, the initial folate result was 15.2 ng/ml.The sample was repeated using a new reagent lot and the result was 8.05 ng/ml.For patient 2, the initial folate result was 8.56 ng/ml.The sample was repeated using a new reagent lot and the result was 6.39 ng/ml.For patient 3, the initial folate result was 10.5 ng/ml.The sample was repeated using a new reagent lot and the result was 7.56 ng/ml.For patient 4, the initial folate result was 12.4 ng/ml.The sample was repeated using a new reagent lot and the result was 9.31 ng/ml.For patient 5, the initial folate result was 10.8 ng/ml.The sample was repeated using a new reagent lot and the result was 7.67 ng/ml.For patient 6, the initial folate result was 18.0 ng/ml.The sample was repeated using a new reagent lot and the result was 10.3 ng/ml.For patient 7, the initial folate result was 10.4 ng/ml.The sample was repeated using a new reagent lot and the result was 6.33 ng/ml.For patient 8, the initial folate result was 8.49 ng/ml.The sample was repeated using a new reagent lot and the result was 4.89 ng/ml.The repeat results were deemed correct.The analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The customer replaced the reagent with a new lot which resolved the issue.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on 20-oct-2022.Calibration attempts between 20-oct - 02-nov-2022 failed due to low signals.It was found that the calibration signal loss for the affected folate assay lot could be confirmed and was determined to be the root cause of the event.The current workaround as described in a customer communication published in may-2022 involves re-calibrating folate every three days, replacing the reagent pack if calibration fails, and switching to a new reagent lot if calibration and qc fail.

• Brand Name: ELECSYS FOLATE III
• Common Device Name: FOLIC ACID TEST SYSTEM
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16021560
• Report Number: 1823260-2022-04123
• Device Sequence Number: 12236312
• Product Code: CGN
• UDI-Device Identifier: 04015630939695
• UDI-Public: 04015630939695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: FOLATE G3
• Device Catalogue Number: 07027290190
• Device Lot Number: 590062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown