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

Catalog Number 04837975001

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated that coaguchek xs meter serial number (b)(4) was not powering on.The stated that the batteries were changed and the meter was cleaned.New (b)(6) batteries are in the meter.The reporter performed a display check of the meter and while the button was being held down, segments in the display were changing.Not all segments in the result field of the display were visible.The reporter stated that "rrr" was visible in the result field, instead of "888".The segments would then disappear, 3 beeps were heard, then nothing appeared on the screen.No adverse events were alleged to have occured.

Manufacturer Narrative

The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination, it was found the printed circuit board (pcb) and battery contacts was contaminated.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.

• Brand Name: COAGUCHEK XS PROF KIT
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8736040
• MDR Text Key: 149255459
• Report Number: 1823260-2019-02330
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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: Health Professional
• Device Catalogue Number: 04837975001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1