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

Catalog Number	07027290190
Medical Device Problem Codes	Failure to Recalibrate (1517); High Test Results (2457); High Readings (2459); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for six patient samples tested with elecsys folate iii on an unknown cobas pure system.The customer noted that the reagent loses stability after 10 days and that calibrations were being rejected due to the calibration factor.The customer noticed that the initial sample values did not agree with the clinical status of the patients, so the samples were sent out to another laboratory for repeat testing on an unknown system.The first sample initially resulted in a folate value of > 20 ng/ml and it repeated as 9.21 ng/ml.The second sample initially resulted in a folate value of > 20 ng/ml and it repeated as 14.1 ng/ml.The third sample initially resulted in a folate value of > 20 ng/ml and it repeated as 10.9 ng/ml.The fourth sample initially resulted in a folate value of 18 ng/ml and it repeated as 6.12 ng/ml.The fifth sample initially resulted in a folate value of 19.8 ng/ml and it repeated as 6.77 ng/ml.The sixth sample initially resulted in a folate value of 20 ng/ml and it repeated as 8.61 ng/ml.
Additional Manufacturer Narrative
The cobas pure analyzer serial number was requested, but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration performed on the day of the event failed due to an invalid calibration factor.Controls run on the day of the event also failed.The investigation confirmed a calibration issue (invalid calibration factor) for multiple folate reagent lots.The calibration issues were observed within the claimed on-board reagent stability.In case the calibration and/or qc fails, the customer should not continue using the reagent pack and switch to a new reagent kit.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19976394
• Report Number: 1823260-2024-02356
• Device Sequence Number: 8460789
• Product Code: CGN
• UDI-Device Identifier: 04015630939695
• UDI-Public: 04015630939695
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K082340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 07027290190
• Device Lot Number: 72804701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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