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

Catalog Number 07464215190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys vitamin d total gen.2 assay on a cobas e 411 immunoassay analyzer.No incorrect values were reported outside of the laboratory.The sample initially resulted with a vitamin d value of > 100.00 ng/ml.The sample was diluted 1:2 and repeated, resulting with a value of > 100.00 ng/ml.The sample was diluted 1:4 and repeated, resulting with a raw value of 66.45 ng/ml, which calculates to a final value of 265.8 ng/ml when accounting for the dilution factor.On (b)(6) 2020, the same was diluted 1:2 and repeated, resulting with a value of > 100.00 ng/ml accompanied by a data flag.The sample was sent to another laboratory for testing with a different method and the vitamin d result was 98.9 ng/ml on (b)(6) 2020.The e411 analyzer serial number was (b)(4).

• Brand Name: ELECSYS VITAMIN D TOTAL II
• 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: 9806109
• MDR Text Key: 220568791
• Report Number: 1823260-2020-00673
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K113546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 07464215190
• Device Lot Number: 42499502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 YR