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

Catalog Number 03666794001

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

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 coaguchek xs meter display issue, which could cause misinterpretation of results.The customer stated the meter lost power, and the right side of the meter's display appeared darkened.The customer reported the display "appears to show a burned appearance." the customer confirmed there was no evacuation, smoking, burning, or melting, the customer replaced the meter's batteries last week due to meter power loss.The customer noticed one of the batteries had leaked inside the meter when the batteries were replaced.The customer cleaned inside the battery compartment prior to placing the new batteries in the meter.The customer was able to turn on the meter, but the meter turned off after pressing the "m" button during testing.The customer was unable to perform a meter display check or confirm if the results field showed missing segments.The customer removed the new batteries and checked the battery compartment for corrosion.No corrosion was observed.The customer confirmed the meter was not dropped or damaged.No misinterpretation of results occurred.

Manufacturer Narrative

The display showed no issues during the investigation.The meter¿s circuit board was tested for damage or contamination and it was found that the battery contacts and printed circuit board are contaminated by liquid (leaked battery) which has penetrated / corroded solder contacts.The observed contamination can 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: 10703729
• MDR Text Key: 213685211
• Report Number: 1823260-2020-02589
• 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: 11/11/2020

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: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1