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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS
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ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS Back to Search Results
Catalog Number 04625374160
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2014
Event Type  malfunction  
Event Description
Caller tested 2.9 inr on the coaguchek xs system while a comparison lab returned as 2.0 inr.No treatment required.No adverse event reported.Requested return of suspect system and replacement was sent.
 
Manufacturer Narrative
It was unknown if the initial reporter sent report to the fda.
 
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Brand Name
COAGUCHEK ® XS SYSTEM
Type of Device
PROTHROMBIN TIME TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 6830 5
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key4371201
MDR Text Key5259374
Report Number1823260-2014-10562
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 01/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/30/2015
Device Catalogue Number04625374160
Device Lot Number22627422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CPAP DEVICE; WARFARIN; PACEMAKER DEFIBRILLATOR
Patient Age053 YR
Patient Weight104
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