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

Catalog Number 06506780160

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi): (b)(4).The customer declined a service visit.

Event Description

The initial reporter questioned dilution results for multiple patient samples tested for elecsys vitamin d (vitamin d) on a cobas 6000 e 601 module.The customer provided an example for 1 patient sample.The initial result was 60 ng/ml with a data flag.The sample was manually diluted 1:3 with a result of approximately 30 ng/ml.Since the diluted result did not match the initial result, the customer repeated the sample with a result of 30 ng/ml.The repeat result was believed to be correct and was reported outside of the laboratory.Product labeling states "the recommended dilution is 1:2.The concentration of the diluted sample must be > 25.0 ng/ml." the customer has switched to using the recommended dilution of 1:2.The e601 module serial number was (b)(4).

Manufacturer Narrative

Section b1, product problem was updated.

Manufacturer Narrative

Calibration and qc were acceptable.The customer manually diluted the sample using a 1:3 dilution.Product labeling states: "samples with vitamin d (25-oh) concentrations above the measuring range can be manually diluted with diluent universal.The recommended dilution is 1:2.The concentration of the diluted sample must be > 25.0 ng/ml(> 62.5 nmol/l).After manual dilution, multiply the results by the dilution factor 2." the investigation determined the event was due to a product handling issue at the customer site.

• 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
• MDR Report Key: 11895079
• MDR Text Key: 270217520
• Report Number: 1823260-2021-01581
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• PMA/PMN Number: K113546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 06506780160
• Device Lot Number: 475482
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1