MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

Catalog Number 05150507001

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The nurse complained of an error message from a coaguchek xs plus meter that was not making sense.The nurse tried to duplicate the error message while dosing the strip with blood and the meter displayed a dosing error, "e-403." the nurse stated the strips had been working with other meters and that the blood filled the entire channel.There was no corrosion seen in the strip guide area.The nurse stated the heater plate appeared to be burnt in a corner.The nurse believes it may be the result of an electrical short.The nurse stated the batteries had been installed incorrectly and had to be reinstalled prior to reporting the issue.There was no adverse event.There were no other signs of burning or melting.The meter has been requested for further investigation.

Manufacturer Narrative

The customer's meter was returned for investigation.The meter's memory was read out and control testing was attempted, but aborted with error message 403.The meter was opened and inspected.The meter did not show any signs of burning.The heater plate had normal wear signs for the high strip count.Contamination of strip contacts with blood was observed as cause for error 403.The observed contamination can lead to the observed error.Medwatch fields have been updated.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: 7605199
• MDR Text Key: 111172110
• Report Number: 1823260-2018-01922
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 05150507001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• 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