ELECSYS VITAMIN D ASSAY VITD TOTAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for ELECSYS VITAMIN D ASSAY VITD TOTAL manufactured by Roche Diagnostics.

Event Text Entries

[143403780] The investigation could not identify a product problem. The cause of the event could not be determined. There were no follow up/corrective actions. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10

[143403781] This report summarizes 1 malfunction event. An erroneous high result was generated by the cobas 6000 e 601 module. The event involved a total of 1 patient with the following: one erroneous result for the elecsys vitamin d assay. The patient's age was (b)(6). There was one male.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2019-90110
• MDR Report Key: 8544216
• Date Received: 2019-04-24
• Date Added to Maude: 2019-04-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MICHAEL LESLIE
• Manufacturer Street: 9115 HAGUE ROAD NA
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer Phone: 3175214343
• Manufacturer G1: ROCHE DIAGNOSTICS GMBH
• Manufacturer Street: SANDHOFFERSTRASSE 116 NA
• Manufacturer City: MANNHEIM (BADEN-WURTTEMBERG), NA 68305
• Manufacturer Country: GM
• Manufacturer Postal Code: 68305
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ELECSYS VITAMIN D ASSAY
• Generic Name: VITAMIN D TEST SYSTEM
• Product Code: MRG
• Date Received: 2019-04-24
• Model Number: VITD TOTAL
• Lot Number: 356555
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-24