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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
Model Number 03666794001
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2018
Event Type  malfunction  
Manufacturer Narrative
Unique identifier (udi)#: (b)(4).
 
Event Description
The customer stated that the coaguchek xs meter displayed set but the display was partial.The customer had replaced the batteries in the meter.The customer then turned the meter on and observed a set flashing with a partial date.The customer performed a display check and noted missing segments in the upper part of the "888s".There was no allegation of an adverse event.The meter was requested to be returned for investigation.
 
Manufacturer Narrative
The device was returned for investigation.The battery compartment and circuit board were contaminated and corroded due to leaking batteries which could lead to contact failure.The investigation was unable to find a definitive root cause.
 
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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 Key7442519
MDR Text Key106737769
Report Number1823260-2018-01211
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 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number03666794001
Device Catalogue Number03666794001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Date Manufacturer Received04/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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