MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AFP ASSAY; KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Catalog Number 04491742190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 2 patient samples tested for elecsys afp assay (afp) that were accompanied by a

Manufacturer Narrative

A specific root cause was not identified.Additional information was requested for investigation but was not provided.A general product problem can be excluded.Possible root causes for this event may be sample quality and insufficient maintenance.

• Brand Name: ELECSYS AFP ASSAY
• Type of Device: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
• 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: 6404349
• MDR Text Key: 69952885
• Report Number: 1823260-2017-00559
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K981282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04491742190
• Device Lot Number: 176747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• 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