MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Model Number B12 G2

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2019

Event Type  malfunction  

Manufacturer Narrative

A field engineering specialist checked the system and found no root cause.Qc results before and after the date of the event were acceptable.The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable elecsys vitamin b12 immunoassay results for 1 patient tested on a cobas e 411 immunoassay analyzer compared to the results from an unspecified method in another laboratory.The initial (sample a) vitamin b12 result was 210 pg/ml.The patient was tested in another laboratory on the same day on an unspecified system (sample b) and had a vitamin b12 result of < 83 pg/ml.Sample a was then sent to a different customer on (b)(6) 2019 and had a vitamin b12 result of 83 pg/ml.Sample a was again tested on the original analyzer and had a result of 202 pg/ml.The results in question were reported outside of the laboratory.The cobas e411 serial number is (b)(4).

Manufacturer Narrative

A general reagent issue can most likely be excluded, since customer¿s qc was found within the specified target ranges.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8870890
• MDR Text Key: 153822190
• Report Number: 1823260-2019-02890
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

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: 01/31/2020
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 38496501
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1