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

Catalog Number	04837975001
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2023-02191
• Device Sequence Number: 18120717
• Product Code: GJS
• UDI-Device Identifier: 00365702126107
• UDI-Public: 00365702126107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown