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

Model Number XS PST

Device Problem Material Discolored (1170)

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

Event Date 05/19/2022

Event Type  malfunction  

Event Description

We received an allegation of a brown scorch-like mark on the heater plate of the coaguchek xs meter.The meter powers off and resets after pressing the "m" button.The reporter cleaned the heater plate to troubleshoot per instructions from the user's manual.The reporter stated that there was a brown scorch-like mark at the bottom left corner and outwards on the heater plate.The mark did not disappear upon cleaning.

Manufacturer Narrative

The meter was requested for investigation.Occupation is patient/consumer: na.

Manufacturer Narrative

The meter was returned for investigation.The meter and circuit board were checked for contamination or damage.Clear contamination from dried blood was seen on the heating ceramic.Blood contamination was be seen on the test strip contacts.No other device contamination was observed.The contamination on the heating ceramic is not a scorch mark, since on closer inspection traces of dried liquid are visible.The energy for such a selective overheating cannot be generated in the device.The root cause is determined to be 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14684039
• MDR Text Key: 302001812
• Report Number: 1823260-2022-01718
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: XS PST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2022
• 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