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

Model Number XS PST

Device Problem Image Display Error/Artifact (1304)

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

There was an allegation of a display issue for a coaguchek xs meter.The device's display has missing segments.During a display check, the "8's" in the middle of the screen were not complete and there were several segments missing.No misinterpretation of a result was reported.

Manufacturer Narrative

Occupation is patient/consumer.The device was requested to be returned for investigation.The investigation is ongoing.

Manufacturer Narrative

Sections d9 and h3 were updated to reflect returned product.The meter was returned.The investigation found that the device's battery compartment is contaminated by a leaked battery and the circuit board is contaminated by penetrated liquid which caused the alleged issue.Product labeling states: "it is important to follow the procedures below to clean and disinfect the meter.Failure to follow these procedures may cause malfunction of the meter.Do not use sprays of any sort; ensure that swab or cloth is only damp, not wet" and "wipe away residual moisture and fluids after cleaning the housing." the investigation determined the issue to be caused by improper handling or maintenance.

• Brand Name: COAGUCHEK ® XS SYSTEM
• 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: 15321138
• MDR Text Key: 305492649
• Report Number: 1823260-2022-02638
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702125100
• UDI-Public: 00365702125100
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2022
• 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