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

Catalog Number 09038078160

Device Problem High Test Results (2457)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

The vitamin d total iii reagent expiration date was not provided.The cobas e411 serial number was (b)(6).The customer stated that the analyzer had been pushed and it was not balanced.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 2 patients' serum samples tested with elecsys vitamin d total g3 ( vitamin d total iii) assay on a cobas e411 immunoassay analyzer.Sample 1 (patient 1): initial result: >80 ng/ml.Repeat result: 14.2 ng/ml.Sample 2 (patient 2) was tested on (b)(6) 2024: initial result: >80 ng/ml.Repeat result: 26.0 ng/ml.The physician questioned the results.The samples were then repeated.The repeat results were deemed to be correct.

Manufacturer Narrative

The customer verbally stated that the qc was out of range on (b)(6) 2024 and they believed that the issue start date was on 05-feb-2024.The field service engineer moved and adjusted the instrument to be leveled and unmovable.He then powered on the instrument and performed a system volume check.The check was successful.The root cause was due to the analyzer being pushed back six inches causing the analyzer to be knocked off its pads.The service actions (moving and adjusting the instrument to be leveled and unmovable) resolved the issue.No further issues were reported afterward.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Type of Device: VITAMIN D ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18787498
• MDR Text Key: 336529684
• Report Number: 1823260-2024-00553
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09038078160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• 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
• Patient Age: 62 YR
• Patient Sex: Female