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	03/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys vitamin d total ii results for 20 patients tested on a cobas 8000 e 801 module serial number (b)(4).Prior to and after the event, the customer stated the qc results were acceptable.The customer reported the questionable results were measured within a "1-2" minute time frame.The initial vitamin d results were not reported outside the laboratory.The customer performed repeat testing with the samples on a different e 801 module.Below are five examples of questionable vitamin d results: patient 1's initial vitamin d result was 9.31 ng/ml, and the patient's repeat result was 14 ng/ml.Patient 2's initial vitamin d result was 37.3 ng/ml, and the patient's repeat result was 9.59 ng/ml.Patient 3's initial vitamin d result was 34 ng/ml, and the patient's repeat result was 9.27 ng/ml.Patient 4's initial vitamin d result was 82.3 ng/ml, and the patient's repeat result was 12.7 ng/ml.Patient 5's initial vitamin d result was 38.3 ng/ml, and the patient's repeat result was 16.1 ng/ml.
Additional Manufacturer Narrative
The field service engineer did not find any problems with the calibration or any other assays.He confirmed the timing of the questionable results occurred when the reagent pack was changed.He performed additional comparison testing with the other e 801 module and had similar results.The investigation is ongoing.
Additional Manufacturer Narrative
The customer's sample preanalytic details were requested but not provided.Product labeling states, "avoid foam formation in all reagents and sample types (specimens, calibrators and controls)." for quality control, product labeling states "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration." based on the provided information, 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13994327
• Report Number: 1823260-2022-00940
• Device Sequence Number: 12034654
• Product Code: MRG
• UDI-Device Identifier: 04015630940127
• UDI-Public: 04015630940127
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 05/09/2022

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: 07028148190
• Device Lot Number: 570755
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/09/2022
• 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