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

Catalog Number 09038086190

Device Problem Non Reproducible Results (4029)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas pure e 402 analytical unit is (b)(6).The field service representative (fsr) calibrated the assay but the issue was not resolved.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys vitamin d total iii results from an unspecified number of patient samples tested on the cobas pure e 402 analytical unit.The initial results were not reported outside of the laboratory as they were considered erroneous and did not coincide with the patient's history.Low results were noted prior to calibration.The patient samples were then rerun after calibration and were also sent for validation to a reference laboratory that uses an e 411.The reporter was able to provide one patient sample with discrepant results: the initial result from the analyzer was 3.92 ng/ml.The first repeat result from the analyzer after calibration was 8.19 ng/ml the second repeat result from the e 411 was 12.0 ng/ml.

Manufacturer Narrative

The investigation reviewed the calibration data on (b)(6) 2023; recalibration on (b)(6) 2023; and calibration on (b)(6) 2023.The last reagent rack pack used had increased calibration signals but was still within specifications.The investigation reviewed the qc data.The qc from (b)(6) 2023 showed a trend in the lower range (-1 standard deviations sd/-2sd) but still within the specified ranges.The qc from (b)(6) 2023 to (b)(6) 2023 showed that qc level 1 trended to lower recoveries, but all within the limits.This can be explained by the general lower recovery of the control material according to the global laboratory performance data.The customer replaced the reagent; improvement was noted.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17904837
• MDR Text Key: 325288337
• Report Number: 1823260-2023-03239
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (y/n): Y
• Reporter Country Code: AR
• PMA/PMN Number: K210901
• 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: 11/10/2023

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: 02/29/2024
• Device Catalogue Number: 09038086190
• Device Lot Number: 71889401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 11/10/2023
• 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