MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL II; VITAMIN D TEST SYSTEM

Catalog Number	07028148190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys vitamin d total ii results for two patients tested on the cobas e 801 analytical unit.The initial results were not reported outside of the laboratory as they did not match the patient's clinical diagnoses alerting the reporter to an issue with the results.Sample (b)(6).The initial result was 250 nmol/l with a data flag.The first repeat result was 38.9 nmol/l.The second repeat result was 38.1 nmol/l.Sample (b)(6).The initial result was >250 nmol/l with a data flag.The repeat result was 70.1 nmol/l.The repeat results were deemed correct. .
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the calibration data and the result was within specifications.There was no influence of the calibration on the issue.The investigation reviewed the qc data and the results were within specifications before the event.The investigation reviewed the customer's handling of patient samples and no issues were noted.The investigation reviewed the images from the sample foam detection (sfd) camera.There was dust on the active gripper wheels.There was no indication of a sample quality issue.Based on the information provided, a general reagent issue was excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL II
• Common Device Name: VITAMIN D 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: 19481658
• Report Number: 1823260-2024-01667
• Device Sequence Number: 18136771
• Product Code: MRG
• UDI-Device Identifier: 04015630940127
• UDI-Public: 04015630940127
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K162840
• 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): 07/03/2024

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: 02/28/2025
• Device Catalogue Number: 07028148190
• Device Lot Number: 77262601
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/03/2024
• 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: Female