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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 No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer stated the display of the coaguchek xs meter was incomplete.A display check was performed and there were no segments present in the in the far right "8" of the display.This could impact the interpretation of results.All segments were present on the other parts of the display.The customer did not use any result obtained on the meter and has sought alternate testing.There was no allegation of an adverse event.The suspect meter was requested to be returned for investigation.Replacement product was sent.
 
Manufacturer Narrative
Customer returned the meter for investigation.Upon investigation of the returned meter, a defect in the circuit board or an electronic component of the circuit board was found.Medwatch fields have been updated.
 
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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 Key7322940
MDR Text Key101995281
Report Number1823260-2018-00707
Device Sequence Number1
Product Code GJS
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 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
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 Manufacturer03/15/2018
Date Manufacturer Received02/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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