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

Model Number XS PST

Device Problem Circuit Failure (1089)

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

The meter was returned for investigation.The investigation is ongoing.Initial reporter occupation was lay user/patient.

Event Description

There was an allegation of an issue with the display of the coaguchek xs meter.When performing a test, an error 5 was observed, which in turn changed to error 9, then back to error 5, and so forth.A display check was performed and it was confirmed that all segments were present and legible.No display issues were noticed when reviewing the memory page on the meter.There was no actual misinterpretation of any result.

Manufacturer Narrative

The customer's meter was returned for investigation.The display showed no error during the investigation.The circuit board had no signs of contamination or defect that could lead to the complained error.

• 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: 12168509
• MDR Text Key: 272013946
• Report Number: 1823260-2021-02031
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1