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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 High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
Unique identifier (udi) (b)(4).Occupation is lay user/patient.The test strips were requested for investigation.The reporter's test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.7 inr, qc 2: 2.7 inr, qc 3: 2.7 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Routine retention testing is performed.Test strip retention samples passed the internal inspection.Retention testing data is reviewed and appropriate actions are taken as needed.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin based laboratory method is compared to other laboratory methods." the investigation did not identify a product problem.The cause of the event could not be determined.
 
Event Description
We received a report of discrepant inr results for 1 patient tested with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.At 4:36 pm, the result from the meter was 6.9 inr.At 6:30 pm, the result from the laboratory was 3.0 inr.The patient has a therapeutic range of 2.0-3.0 inr.
 
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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 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key11417397
MDR Text Key256386141
Report Number1823260-2021-00653
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 Other
Type of Report Initial
Report Date 03/04/2021
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 Lay User/Patient
Device Expiration Date04/30/2021
Device Catalogue Number04625374160
Device Lot Number43002022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Initial Date Manufacturer Received 02/10/2021
Initial Date FDA Received03/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age53 YR
Patient Weight137
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