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 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s products have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.

Event Description

The initial reporter had an issue with the coaguchek xs meter that could lead to a misinterpretation of results.The customer stated the meter had an "error 8" per product labeling, this error indicated an error occurred during the internal diagnostic test.The customer replaced the batteries and still received an "error 8".The customer stated the meter display showed a flickering screen.The customer performed a display check which showed no missing segments but the numbers were flickering in the result field.

Manufacturer Narrative

The customer's meter was received for investigation.The meter could not be powered on.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board was contaminated.The root cause is determined to be contamination due to improper handling or maintenance by the customer.Medwatch fields d9 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: 10445286
• MDR Text Key: 204222638
• Report Number: 1823260-2020-02083
• 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: 09/18/2020

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: 08/25/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1