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

Catalog Number	07464215160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The customer received questionable elecsys vitamin d gen 2 assay results for qc material and an unknown number of patient samples from 06-jul-2018 through 11-jul-2018 from cobas 6000 e 601 module serial number (b)(4).Of the data provided for eight patient samples tested on (b)(6) 2018, only the data for one patient sample was discrepant.The initial result was 39.39 ng/ml and the repeat result was 82.83 ng/ml.The repeat result was believed to be correct.The customer followed up with the physicians and provided the corrected result.There was no adverse event.The customer believed there was a reagent issue.
Additional Manufacturer Narrative
The qc and calibration data provided is within acceptable range.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL II
• Common Device Name: VITAMIN D TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7730834
• Report Number: 1823260-2018-02494
• Device Sequence Number: 16494994
• Product Code: MRG
• UDI-Device Identifier: 07613336129197
• UDI-Public: 07613336129197
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 07464215160
• Device Lot Number: 29833301
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR