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

Catalog Number 07028148190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2022

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 296766022
• Report Number: 1823260-2022-00940
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 04015630940127
• UDI-Public: 04015630940127
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 07028148190
• Device Lot Number: 570755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1