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

Catalog Number 09038078160

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

Na h3 other text : na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys vitamin d total iii on cobas e411 rack analyzer serial number (b)(6).The patient sample initially resulted in a vitamin d value of 19.36 ng/ml and this value was reported outside of the laboratory.The sample was repeated, resulting in a value of 29.45 ng/ml.The repeat value was deemed correct.

Manufacturer Narrative

Calibration signals recovered within expectations and quality controls recovered within range.Upon review of the alarm trace, insufficient sample volume and clot pipetting errors were observed.These can indicate a potential sample quality issue.The field service engineer could not find any hardware issues.The probe alignments were adjusted.The liquid level detection voltage was checked and was within specifications.Performance testing passed.The investigation could 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 ASSAY
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17100318
• MDR Text Key: 316895300
• Report Number: 1823260-2023-01929
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 07613336184615
• UDI-Public: 07613336184615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210901
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 09038078160
• Device Lot Number: 66279701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• 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