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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 03666794689
Device Problem Unable to Obtain Readings
Event Date 07/29/2015
Event Type  Injury  
Event Description

The patient reported being unable to obtain an inr result on the coaguchek xs system due to a device error. The reported error (error 7) can occur when a patient has an inr result >8. 0 inr. The following day the patient went to the hospital; a lab value returned as 14. 5 inr and the patient was treated with 5 units of plasma and vitamin k. The patient's coumadin dose was held based on the lab value. The patient went home the same day as the incident. Requested return of suspect system and replacement was sent.

 
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Brand NameCOAGUCHEK ® XS SYSTEM
Type of DevicePROTHROMBIN TIME MONITOR
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250
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 Key5057854
Report Number1823260-2015-04107
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 09/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue Number03666794689
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Unknown
Date Manufacturer Received08/12/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/04/2015 Patient Sequence Number: 1
Treatment
METHADONE
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