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

Catalog Number 04837975001

Device Problem Circuit Failure (1089)

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

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).The customer¿s meter was requested for return.The investigation is ongoing.

Event Description

There was a complaint of a display issue with coaguchek xs meter serial number (b)(4).The customer indicated that the meter is stuck in the full display screen.She is unable to power the meter off as the display continues to show even when the power button is pressed.The meter then reverts to set mode and exits full display.The customer also indicated she was unable to power the device off as it did not seem to respond and the full display continues to display on the screen.It was noted that the display was a tad shaky, but the 8's in the results field were complete and legible.The decimal point within the 8's has a clear line across it.The line did not impede the visibility of the numbers or messages on the screen but it's located within the results field.

Manufacturer Narrative

The customer returned their coaguchek xs meter serial number (b)(6) for investigation.The display shows no error during the investigation (no missing or fainted segments).The circuit board shows no contamination that could lead to the complained error during the investigation.The device showed no customer mishandling/user error during the investigation.Regarding the "clear line in the decimal point within the eights": this "clear line" is always to be seen between all segments on the display, since the decimal point consists of two segments with a small distance between them.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COAGUCHEK XS PROF KIT
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11605953
• MDR Text Key: 245852828
• Report Number: 1823260-2021-00990
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1