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

Model Number XS PLUS

Device Problems No Device Output (1435); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

A technician opened the meter and saw that a cable was not properly connected.Once the cable was reconnected the problem did not persist.The meter was requested for investigation.

Event Description

There was a complaint that the whole coaguchek xs plus meter display was suddenly faint.The display could not be read properly, including the area displaying test results.The device had not been used since and there was no misinterpretation of the results.

Manufacturer Narrative

The meter was returned for investigation.The meter error memory was read out and contained the e211 error (lid opened during measurement) and e205 (strip was removed erroneously during measurement).The meter was visually examined for contamination with blood.Blood was observed to be smeared on the test strip contacts.As a result, the test strip is no longer recognized shortly after it has been inserted and is displayed as an e205 error.The circuit board was also examined and found to be contaminated with blood and cleaning agent.This contamination can lead to the reported error messages.The root cause is determined to be contamination of the test strips contacts and circuit board due to improper handling or maintenance by the customer.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12388156
• MDR Text Key: 272896054
• Report Number: 1823260-2021-02529
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XS PLUS
• Device Catalogue Number: 04800842190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1