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

Catalog Number 05021537001

Device Problem No Device Output (1435)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for investigation.

Event Description

We received an allegation of an intermittent display issue on a coaguchek xs plus meter.The customer alleges that the meter will display an inr result for a few seconds after running a test and then the result will disappear and the meter returns to the main menu.The hourglass will then reappear on the display screen.None of the results from this issue were located in the meter memory.

Manufacturer Narrative

The meter was received for investigation.Sections d9 and h3 were updated.Obvious signs of mechanical impact were visible on the meter's casing.The meter was disassembled for further investigation of the electronic parts.No abnormalities were observed with the electronic parts, however, contamination was identified.A broken heater ceramic and damage around where the test strip is inserted were identified.The observed damage is due to a strong impact or a fall.The investigation determined the issue was due to improper handling of the device by the customer.

• Brand Name: COAGUCHEK XS PLUS
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16333160
• MDR Text Key: 309185855
• Report Number: 1823260-2023-00413
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702164109
• UDI-Public: 00365702164109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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 Catalogue Number: 05021537001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1