MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PROF KIT; COAGUCHEK ® XS SYSTEM

Catalog Number 04837975001

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer stated the display of the coaguchek xs meter was faint and segments were missing from the results area.This could possibly lead to a misinterpretation of patient results.There was no allegation of an actual misinterpretation of results or any adverse event.The meter was requested to be returned for investigation.Replacement product was sent.

Manufacturer Narrative

The customer's meter was received for investigation.The circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated by liquid which has penetrated and/or corroded the solders contacts.Between the conductive rubber and the contacts of the circuit board, deposits could be seen which led to the failure of contacts.

Manufacturer Narrative

The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.There was no malfunction of the device.

• Brand Name: COAGUCHEK XS PROF KIT
• Type of Device: COAGUCHEK ® XS SYSTEM
• 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: 7159615
• MDR Text Key: 96240134
• Report Number: 1823260-2018-00037
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• 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