MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASSAY TIP/CUP ELECSYS MODULARE170; EQUIPMENT, LABORATORY, GENERAL PURPOSE

Model Number E601

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received erroneous results for an unspecified number of patient samples tested for multiple assays on the cobas 6000 e 601 module.No erroneous results were reported outside of the laboratory.No specific patient result data was provided.The reporter determined the issue was related to the assay cup consumables used on the system.The cups were defective.The affected lot number of the cups is 19817113.No adverse events were alleged.

Manufacturer Narrative

The root cause of the issue was related to a defective lot of assay cup consumables used on the system.The affected cup lot was confirmed to have holes 0.06 to 0.15 mm.The affected lots were not distributed in the united states.

• Brand Name: ASSAY TIP/CUP ELECSYS MODULARE170
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8591187
• MDR Text Key: 144484471
• Report Number: 1823260-2019-01735
• 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
• Report Date: 08/23/2019

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: E601
• Device Catalogue Number: 12102137001
• Device Lot Number: 19817113
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1