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

Model Number VITD TOTAL

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received questionable results for two patients sample tested with the elecsys vitamin d assay on a cobas e 411 immunoassay analyzer.The second patient sample was also tested on a cobas 6000 e 601 module and a cobas pro e 801 module.The first sample initially resulted in a vitamin d value of > 70 ng/ml when tested on the customer's e411 analyzer.The sample was repeated on an abbott analyzer, resulting in a value of 28.5 ng/ml.No incorrect results were reported outside of the laboratory for this sample.The second sample initially resulted in a vitamin d value of > 70 ng/ml when tested on the customer's e411 analyzer.The sample was repeated on an abbott analyzer resulting in a value that was much lower.The specific value measured with the abbott analyzer was not provided.The sample was sent to a second laboratory for testing on an e601 analyzer, resulting in a value of 49.64 ng/ml.The sample was also sent to a third laboratory for testing on an e801 analyzer where it resulted in values of 46.2 ng/ml and 53.3 ng/ml on (b)(6) 2021.It was asked, but it is not known if any incorrect results were reported outside of the laboratory for this sample.The customer believed the abbott values to be correct based on the clinical picture of the patients.The e411 analyzer serial number is (b)(4).Vitamin d reagent lot number 58937301, with an expiration date of 30-nov-2022 was used on this analyzer.The serial number of the e601 analyzer was requested, but not provided.Vitamin d reagent lot 589373, with an expiration date of 30-nov-2022 was used on this analyzer.The serial number of the e801 analyzer was requested, but not provided.Vitamin d reagent lot 568206 was used on this analyzer.The reagent expiration date was requested, but not provided.

Manufacturer Narrative

No incorrect results were reported outside of the laboratory for the second sample.The repeat measurements for the second sample were considered more reliable.

Manufacturer Narrative

The last calibration was performed on the e411 analyzer on 13-dec-2021 and signal counts were within expectations.The assay is calibrated regularly.Data for one level of control was provided for the e411 analyzer and was within range during the event.In the provided data, controls were out of range 2 times.Data for one level of control was provided for the e602 analyzer and was within range on (b)(6) 2021.Controls tested on the e 801 analyzer were within range on (b)(6) 2021.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D ASSAY
• 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: 13096086
• MDR Text Key: 290457843
• Report Number: 1823260-2021-03894
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K113546
• 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,Followup
• Report Date: 02/22/2022

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 Expiration Date: 11/30/2022
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 58937301, 589373, 568206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 12/29/2021; 01/28/2022
• Supplement Dates FDA Received: 01/06/2022; 02/22/2022
• 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