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

Catalog Number 05530199160

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The customer stated they had an electrical event that affected the base unit and the meter.The customer stated they were affected by a power surge.The customer then stated that they were replacing network cables and discovered burn marks to the back of the base unit and the meter.The base unit has a visible burn mark on it where the unit comes into contact with the meter.The meter has a rechargeable battery pack that is bulging from heat and it shows visible signs of burning where it comes in contact with the base unit.There was no adverse event.The serial number for the coaguchek handheld base unit is (b)(4).The suspect product was requested to be returned and the replacement was sent.This medwatch is for the meter.Please see the medwatch with patient identifier (b)(6) for the information on the base.

Manufacturer Narrative

A specific root cause for the event could not be determined.The product was not returned for investigation.The suspect product was not returned.

• Brand Name: COAGUCHEK XS PRO 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: 5893421
• MDR Text Key: 52737989
• Report Number: 1823260-2016-01244
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05530199160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• 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