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

Catalog Number 05694302001

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys vitamin b12 ii results for 2 patient samples on a cobas e 801 module.Sample 1: the initial result was 100 pg/ml with a

Manufacturer Narrative

The reagent lot number is 740845.The expiration date was not provided.The analyzer serial number is (b)(6).The investigation is ongoing.

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.The 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
• MDR Report Key: 18660627
• MDR Text Key: 334783010
• Report Number: 1823260-2024-00357
• 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
• Report Date: 05/10/2024

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 Catalogue Number: 05694302001
• Device Lot Number: 23274776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/10/2024
• 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