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

Catalog Number 12102137001

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of an issue with assay tip/cups from a particular batch number used with a cobas 6000 e 601 module with serial number (b)(4).There are cracks in the cups and the customer noticed a leak.When the customer switched to a different batch number there were no issues.A crack in the assay cup resulting in a leak could impact patient results.There was no allegation that questionable or erroneous results were generated at the customer site due to the leaking assay cup.There was no allegation that an adverse event occurred.The assay cups were requested for investigation.

Manufacturer Narrative

The customer stated that questionable results were generated due to the leaking assay cups, however, those results could not be provided as they have been deleted at the customer site.

Manufacturer Narrative

The investigation determined the specification for the assay cups were not met; holes were confirmed in the affected assay cups.The customer is advised to use a different lot of assay cups.

Manufacturer Narrative

The affected assay cups with lot 19817113 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: 8594328
• MDR Text Key: 144555506
• Report Number: 1823260-2019-01740
• 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,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 Catalogue Number: 12102137001
• Device Lot Number: 19817113
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 04/16/2019; 04/16/2019; 04/16/2019
• Supplement Dates FDA Received: 05/24/2019; 08/01/2019; 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1