MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL III; VITAMIN D ASSAY

Catalog Number	09038078160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys vitamin d assay results for 1 patient sample on a cobas e 411 immunoassay analyzer.The initial vitamin d result was >120 ng/ml with flag.The sample was repeated as the customer has an internal policy to repeat all vitamin d results above 120 ng/ml.A 1:2 manual dilution was made of the sample and the result was 74 ng/ml.A second 1:2 manual dilution was made of the sample and the result was 62.66 ng/ml.The repeat result of 62.66 ng/ml was deemed correct.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) replaced the mixer motor and performed mechanical checks.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023.The qc recovery data provided was not acceptable on the day of the event.The alarm trace did not contain a conspicuous event.It was found that the customer centrifuges patient samples for 5 minutes, which may be too short.The customer stated that there was fibrin present in the patient sample.The customer performed calibration and qc successfully after the field service engineer visit.No further issues were reported after the service visit.The investigation did not identify a product problem.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Common Device Name: VITAMIN D 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: 18326079
• Report Number: 1823260-2023-03985
• Device Sequence Number: 12521402
• Product Code: MRG
• UDI-Device Identifier: 07613336184615
• UDI-Public: 07613336184615
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/01/2024

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 Catalogue Number: 09038078160
• Device Lot Number: 718918
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/01/2024
• 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 Age: 58 YR
• Patient Sex: Male