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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS SYSTEM; PROTHROMBIN TIME MONITOR
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ROCHE DIAGNOSTICS COAGUCHEK XS SYSTEM; PROTHROMBIN TIME MONITOR Back to Search Results
Catalog Number 03666794001
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
Manufacturer Narrative
The customer's meter was requested for investigation and a replacement meter was sent to the customer.Initial reporter occupation - the occupation is lay user/patient.
 
Event Description
It was reported that there was an issue with the display of coaguchek xs meter serial number (b)(4).The meter display had missing segments in the results field.There have been no misinterpreted results.The meter batteries were changed, but segments were still missing from the results field when a display check was performed.
 
Manufacturer Narrative
The customer's meter was received for investigation.The meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.
 
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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 Key12438912
MDR Text Key273123046
Report Number1823260-2021-02636
Device Sequence Number1
Product Code GJS
UDI-Device Identifier04015630945689
UDI-Public04015630945689
Combination Product (y/n)N
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number03666794001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Date Manufacturer Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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