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

Model Number XS PST

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s device was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter stated they had an issue with the display for the coaguchek xs meter, which could affect the interpretation of the customer¿s results.The device's display is cloudy and has faded segments.No actual misinterpretation of a result occurred.The customer stated she might have left the meter outside in the sun.

Manufacturer Narrative

The customer's meter was received for investigation.The device did not turn on during investigation, therefore the errorlog could not be read out.Contamination observed on the battery contacts caused a power interrupt, therefore it is not possible to turn on the meter.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board was contaminated.The observed contamination can temporarily lead to the reported display issue.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.Medwatch fields d10 and h3 were updated.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10378008
• MDR Text Key: 202052333
• Report Number: 1823260-2020-01914
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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: 03666794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN; LOVENOX; COUMADIN; LOVENOX