MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PLUS HANDHELD BASE UNIT; PROTHROMBIN TIME MONITOR

Catalog Number 04803710001

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  malfunction  

Event Description

The initial reporter stated that the coaguchek handheld base unit was emitting smoke.There was no adverse event.The customer immediately disconnected the power supply.The device was requested to be returned for investigation.

Manufacturer Narrative

Request from fda: did the customer actually see the smoke came off from the device or they only smelt smoke-like? please clarify "emitting smoke".If the customer saw the smoke came off from the device, how would roche was able to plug the device and observed for smoke.Please clarify.Response from manufacturer: on the initial call, the customer stated that they saw smoke.We called the customer back to try to quantify the amount of smoke.Unfortunately the contact person indicated this situation was detected by someone at one of their off site facilities.She stated she would not know which employee to contact and since she was not there, she has no knowledge of how much smoke was coming from the device.Response from manufacturer: also, when the first level investigation unit plugged the unit in to observe for smoke, the base unit led was functional and displayed green as it should the entire time it was plugged in.

Manufacturer Narrative

Request from fda: would you please tell me more about the incident with one of the customers which the handheld base unit was emitting smoke on (b)(6) 2019? did the customer call roche? response from manufacturer: yes, the customer called roche to report the incident.Request from fda: any follow up regarding the investigation for this malfunction? response from manufacturer: the unit was returned by the customer and received by roche.The first level investigation unit performed a visual inspection.The base unit did not have any outward signs of an electrical short.The base unit was plugged in and no smoke was observed.The base unit did have a smell like the electronics may been hot at one time.Response from manufacturer: the base unit will be investigated by the investigation unit in (b)(6).Request from fda: did roche give the customer a different handheld or any replacement? response from manufacturer: yes, roche provided a replacement base unit to the customer.Request from fda: do you have info regarding to follow up with the customer? response from manufacturer: there has been no additional follow up with the customer at this point.

Manufacturer Narrative

The patient¿s handheld base unit was returned for investigation.Upon investigation of the returned device, the printed circuit board that contains the ethernet transformer shows traces of smolder and has been damaged.The ethernet transformer cannot be damaged during regular use of the handheld base unit.Damage was caused by improper use.

Manufacturer Narrative

Request from fda: i wonder if you have received any results from the investigation in (b)(4) regarding this mdr.Please let me know.Response from manufacturer: the device was disassembled for investigation.During visual inspection of the unit it was confirmed that the data transformer l503 on uds4.X extension printed circuit board (transformer for galvanic isolation of the ethernet interface) showed traces of heat stress and had been damaged.The voltage of the data signals of an ethernet line is too low to cause such damage.After starting up the base, it could be successfully connected to the pc via usb-drive.The unit did not get hot.Response from manufacturer: here is additional information related to the investigation: the transformer on the board shorted out, basically opening the circuit and stopping the current flow preventing additional heat.While the cause of the issue could not be determined, we do know that the issue could not be caused directly by the base unit as there is not enough voltage over the ethernet line to cause this.Although it cannot be confirmed, one possible cause is that the user incorrectly plugged in an rj25 cable to the rj45 connection port of the base unit causing a short-circuit over the rx-part of the ethernet transmitter.The operator¿s manual instructs the user to connect to the ethernet with an rj 45 connector into the appropriate port.The rj25 connector cannot be connected to the base unit without force.It is noticeable that plug does not fit.We could not confirm this possibility with the initial reporter.The facility is a multi-site facility and it is not known by the initial reporter which employee had the issue.The initial reporter stated that it is not possible to obtain any additional information about the event.The unit is certified to ul 61010-1 safety requirements for electrical equipment for measurement, control, and laboratory use - part 1: general requirements.It is not likely that additional damage would happen as the affected electrical components interrupts the connection, stopping the current flow and prevent additional heat.We have not had similar complaints with the base unit.

• Brand Name: COAGUCHEK XS PLUS HANDHELD BASE UNIT
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 8417143
• MDR Text Key: 138680000
• Report Number: 1823260-2019-01039
• 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,Followup,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04803710001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2019
• 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