MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASSAYTIP/ASSAYCUP TRAY; EQUIPMENT, LABORATORY, GENERAL PURPOSE

Model Number E801

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in nor.- attachment: [patient results mdr-29901.Pdf].

Event Description

The customer provided data for 4 patient samples tested on cobas e801 module serial number (b)(4).Based on the data provided the results for all 4 patient samples were discrepant when tested for folate, tsh or vitamin b12.Refer to attached data for the patient results.It is not known if any erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.No reagent lot numbers or expiration dates were provided.

Manufacturer Narrative

The root cause of the issue was related to defective assay tips.The tip lot used is covered by a roche initiated recall.Customer was informed to stop using the affected tips.

Manufacturer Narrative

The alarm trace does not contain any information relevant to the event.The investigation found the root cause was poor adjustment of the sampling area (sample probe rotation, tube gripper, and camera alignment).

• Brand Name: ASSAYTIP/ASSAYCUP TRAY
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8150354
• MDR Text Key: 130554002
• Report Number: 1823260-2018-04757
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2019

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 Model Number: E801
• Device Catalogue Number: 05694302001
• Device Lot Number: 18668170
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 11/13/2018; 11/13/2018
• Supplement Dates FDA Received: 01/07/2019; 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 83646
• Patient Sequence Number: 1