MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HUMAN CHORIONIC GONADOTROPIN, STAT (SHORT TURN AROUND TIME); SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number 03271749190

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The expiration date of the reagent is 05/2017.

Event Description

While using the cobas e411 disk (serial number (b)(4)), the customer received questionable results for 2 patient samples for human chorionic gonadotropin, stat (hcg).Of the data provided, one result was erroneous.On (b)(6) 2016, the sample had a result of around 11 miu/ml.This result was not observed in the data that was retrieved from the device.The sample was repeated on (b)(6) 2016 and the sample produced a result of 0.100 miu/ml that was accompanied by a data flag.This is the result the customer deemed to be correct.There was no controls run on (b)(6) 2016.On (b)(6) 2016 only a level one control was performed.There was no adverse event.A specific root cause could not be identified.Additional information for further investigation was requested but not provided.Based upon the information provided, a temporary instrument issue and improper pre-analytical conditions are possible causes.

• Brand Name: HUMAN CHORIONIC GONADOTROPIN, STAT (SHORT TURN AROUND TIME)
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: 5739701
• MDR Text Key: 48785262
• Report Number: 1823260-2016-00791
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K002148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03271749190
• Device Lot Number: 131960
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• 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