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 (b)(6).

Event Description

The customer questioned low results for multiple patients tested for elecsys ferritin (ferritin), elecsys ft4 iii (ft4 iii), elecsys tsh (tsh), elecsys vitamin b12 ii (vitamin b12 ii) and elecsys folate (folate) on a cobas e801 module.The customer provided data for 9 patient samples.Of the data provided, the results for 6 patient samples were discrepant when tested for ferritin, ft4 iii and tsh.There was no allegation that an adverse event occurred.The ferritin reagent lot number was 308327.The expiration date was not provided.The ft4 iii reagent lot number was 331807.The expiration date was not provided.The tsh reagent lot number was 331814.The expiration date was not provided.The field service engineer (fse) visited the customer site but did not identify any instrument issues.The investigation is ongoing.

Manufacturer Narrative

Suspect medical device and applicable fields of section were updated.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

No issues were identified during a review of the alarm trace data.Extensive analysis of instrument data and the sample foam detection images from the instrument were reviewed.The investigation determined the event occurred due to reduced transfer of sample volume due to a poor adjustment of the components of the sampling area.The components of the sampling area were adjusted.The investigation reviewed images from the instrument and the components appear to be adjusted properly, providing good support to the sample.

• 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: 8008600
• MDR Text Key: 126375860
• Report Number: 1823260-2018-03862
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• 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: 10/08/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 10/08/2018; 10/08/2018
• Supplement Dates FDA Received: 01/08/2019; 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 83646
• Patient Sequence Number: 1