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 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The customer noted that all 4 battery contacts in the battery compartment were corroded.He stated the meter had not been exposed to liquid.The meter was requested for investigation.

Event Description

We received an allegation of a display issue with a coaguchek xs meter.A display check was performed and the customer alleged that "everything is scrambled." the "888" in the results field looked like "666." when the meter memory was reviewed, there was a result of either 2.1 or 2.2; the customer stated he could only see the first 2.The customer stated the results were very clear the last time he tested.He stated there was no chance of misinterpreting results; he hasn¿t tested since he noticed the missing segments.

Manufacturer Narrative

Sections d9 and h3 were updated.The meter was received for investigation.The meter could not be turned on.A visual examination was performed.The battery contacts in the battery compartment and the circuit board were contaminated by liquid (leaked battery) which penetrated and corroded the solder contacts.This affects the area of the conductive rubber contacts on the circuit board and caused the issue the customer complained about.The investigation determined the cause of the event was contamination of the contacts due to improper handling or maintenance by the customer.

• 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: 15405017
• MDR Text Key: 305888527
• Report Number: 1823260-2022-02802
• 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

• 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
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 10/13/2022
• 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
• Patient Sex: Male