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

Catalog Number 12102137001

Device Problems Hole In Material (1293); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer was contacted on (b)(6) 2016 and it was determined that the customer had an issue with patient sample results due to an issue with assay cups used on the e602 analyzer.The assay cups had holes in them.The customer stated alarms occurred on the analyzer on (b)(6) 2016.A clinician contacted the laboratory on (b)(6) 2016 explaining a patient result was not possible.Based on the alarms and the possibility the cups affected the results, the customer decided to repeat samples that were initially tested around the time of the alarms.Of the repeated samples, 5 had questionable results.Of the 5 samples, 3 had erroneous results that were reported outside of the laboratory for the elecsys tsh assay (tsh).All 3 samples were repeated on (b)(6) 2016 after changing the assay cups.The customer called the clinician to amend the results.The first sample initially resulted as <0.005 ui/ml.The sample was repeated, resulting as 1.11 ui/ml.The second sample initially resulted as <0.005 ui/ml.The sample was repeated, resulting as 1.75 ui/ml.The third sample initially resulted as <0.005 ui/ml on (b)(6) 2016.The sample was repeated, resulting as 1.33 ui/ml.The patients were not adversely affected.The tsh reagent lot number and expiration date were requested but not provided.The e602 analyzer serial number was requested but not provided.The laboratory is no longer using the lot in question.

Manufacturer Narrative

The field service engineer cleaned the analyzer and the laboratory removed all assay cups of lot 16418713.A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.An issue with sample handling or an instrument issue could not be excluded.It is very likely that the observed issue was caused by damaged assay cups of lot 16418713.Damaged assay cups of lot 16418713 have been confirmed.As a workaround, other lot numbers are available for use.

• 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: 6073043
• MDR Text Key: 59065003
• Report Number: 1823260-2016-01708
• 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
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

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?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• 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