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

Catalog Number 07464215190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

Calibration signals were acceptable for the last calibration performed on (b)(6) 2019.Quality control recovered low, but was still within the acceptable range on the day of the event.Only one level of control was tested on the day of the event.Product labeling indicates: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration." upon review of the alarm trace, no relevant alarms occurred on the day of the event.The investigation could not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).

Event Description

The initial reporter stated they received questionable results for 11 patient samples tested with the elecsys vitamin d total gen.2 assay on a cobas 6000 e 601 module.The reporter changed the reagent pack, calibrated it, and ran controls.The samples were then repeated.Data was provided for 6 patient samples and of these, two had discrepant vitamin d results which are reportable as a malfunction.No incorrect patient results were reported outside of the laboratory.The first sample initially resulted with a vitamin d value of 101.9 nmol/l, which repeated as 62.57 nmol/l.The second sample initially resulted with a vitamin d value of 102.6 nmol/l, which repeated as 65.72 nmol/l.The e 601 analyzer serial number is (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: 9174372
• MDR Text Key: 217307702
• Report Number: 1823260-2019-03650
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: SR
• 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: 10/10/2019

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: 02/29/2020
• Device Catalogue Number: 07464215190
• Device Lot Number: 40800600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/10/2019
• 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