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

Catalog Number 04837975001

Device Problem Image Display Error/Artifact (1304)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

There was an allegation of a screen display issue on a coaguchek xs pro meter, serial number (b)(6).The customer stated that they had received an error 8 on the meter and that it was flickering in the results field.Per product labeling, "error: internal error error during the internal checks which the meter performs.Solution: power the meter off and remove the batteries.Wait at least one minute before re-inserting the batteries in the battery compartment, and then set the date and time as described in the meter set-up section of this manual.Repeat the test.If the error message persists, the meter has a defect.Contact your roche representative." the customer replaced the batteries but the error 8 persisted.There was no misinterpretation of results.

Manufacturer Narrative

The meter was requested for investigation.Replacement product was sent.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.H3 other text : na.

Manufacturer Narrative

The meter was returned for investigation.The device showed error 8 when powered on.The display did not show any noticeable errors or flickering during the investigation, though scratches on meter display were observed.The investigation found that the meter circuit board was contaminated by residues of penetrated liquid and there was evidence of blood contamination due to user mishandling.Per product labeling, "do not let liquid accumulate near any opening.Make sure that no liquid enters the meter.Wipe away residual moisture and fluids after cleaning the housing.Allow wiped areas to dry for at least 10 minutes before performing a test.".

• Brand Name: COAGUCHEK XS PROF KIT
• 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: 17270329
• MDR Text Key: 318832746
• Report Number: 1823260-2023-02191
• Device Sequence Number: 1
• Product Code: GJS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

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: 04837975001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1