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

Catalog Number 05694302001

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

The folate reagent lot number was 725877.The reagent expiration date was requested, but not provided.All other reagent lot numbers and expiration dates were requested, but not provided.Folate calibration data and vitamin b12 qc data were provided.Both qc and calibrations were within expectations.Upon review of the alarm trace, no relevant alarms were observed.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for three patient samples tested on the cobas e 801 analytical unit.Results from the following assays were affected: elecsys vitamin b12 ii, elecsys cea, elecsys tsh, elecsys ft3 iii, elecsys ft4 iv, and elecsys folate iii.Refer to the attachment for all patient data.

Manufacturer Narrative

Medwatch fields d1, d2, d4, g1, and g4 have been updated.

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.The affected tip lot was not distributed in the united states.

• Brand Name: ASSAYTIP/ASSAYCUP TRAY
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18588251
• MDR Text Key: 334836094
• Report Number: 1823260-2024-00236
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 05694302001
• Device Lot Number: 23274776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/02/2024; 04/30/2024
• Supplement Dates FDA Received: 02/22/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1