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

Model Number XS PST

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

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation is lay user/patient (patient¿s wife).The meter was requested for investigation.

Event Description

There was a complaint about an issue with the meter display on coaguchek xs meter serial number (b)(4).The patient¿s wife stated the display is faded and she can't make out the numbers.The patient¿s wife performed a display check and missing segments were noted in the result field.She stated there were zeros instead of eights.She also stated one side of the zeros is darkened and the other side is faded.The patient¿s wife stated the meter had not been damaged and was stored properly.

Manufacturer Narrative

The customer's meter was received for investigation.The display showed no error during investigation.The investigation shows that the battery compartment is contaminated by a leaked battery and the circuit board is contaminated by penetrated liquid which affects the conductive rubber contacts.This can temporarily cause the complained errors.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: 12461083
• MDR Text Key: 272771453
• Report Number: 1823260-2021-02677
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• 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: 04837738001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1