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 10/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable low elecsys afp assay results for one patient sample from cobas e602 analyzer serial number (b)(4).The results were 1.93 ng/ml, 6.00 ng/ml with a 1:10 dilution, and 2.02 ng/ml as the previous result for the patient had been about 10,000 ng/ml, the customer tested another sample from the patient drawn at the same time as the suspect sample and the result was about 10,000 ng/ml.Information concerning if any result was reported outside the laboratory was requested, but it was unknown.The patient was not adversely affected.

Manufacturer Narrative

As part of the investigation, the sample from the patient that generated the result 2.02 ng/ml of was tested and the customer's result was reproduced.Elecsys: 1.83 ng/ml, lumipulse: 2.2 ng/ml.Based on the data available, a specific root cause could not be determined.The sample does not have a non-specific reaction or prozone phenomenon.Additional sample was not available for further testing.

• 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: 6090305
• MDR Text Key: 59577563
• Report Number: 1823260-2016-01752
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• 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: 120174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2016
• 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
• Patient Age: 73 YR