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

Catalog Number 03666794001

Device Problems Circuit Failure (1089); Display Difficult to Read (1181)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The customer¿s device was requested for investigation, but has not been returned.The investigation is ongoing.

Event Description

The initial reporter complained of a cc-xs meter display issue, which could cause misinterpretation of results.The reporter stated the meter has provided unknown errors and power issues.The reporter performed a display test, and segments were missing from the results field and date field.Since the meter display issue was discovered, the patient has only used the meter two times for testing.The patient has been getting blood drawn for laboratory testing.No misinterpretation of results or serious injuries were reported.

Manufacturer Narrative

The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board was contaminated.The observed contamination can temporarily lead to the reported display issue.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.Medwatch fields d9 and h3 were updated.

• 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: 10487631
• MDR Text Key: 206146895
• Report Number: 1823260-2020-02180
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1