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

Catalog Number 12102137001

Device Problems Hole In Material (1293); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(6).

Event Description

The customer initially stated that they received an alarm on the e601 analyzer.When the field service engineer visited the site, it was determined that the assay cups used on the analyzer were damaged.The laboratory had been using the cup lot since (b)(6) 2016.Initially, the customer did not know if there were any false patient results generated due to the issue.The customer later mentioned that they received a high frequency of patient results with decreased values for the elecsys tsh assay (tsh) and increased values for the elecsys ft4 assay (ft4).These results were accompanied by alarms.The customer was asked to provide specific result values and to explain which alarm accompanied the results, but no information has been provided.It was explained that about (b)(4) of the cups within the lot were correct, (b)(4) had a hole in them, and about (b)(4) were deformed with plastic concentrated at the bottom of the cups.No adverse events occurred for this event.The serial number of the e601 analyzer was asked for, but not provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Investigations have confirmed the customer allegation of damaged assay cups for lot 16418713.

Manufacturer Narrative

Further investigation has determined the lot numbers impacted by this issue have not been received or 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6067132
• MDR Text Key: 59220153
• Report Number: 1823260-2016-01675
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2016

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: 16418713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/02/2016; 11/29/2016; 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1