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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 08/10/2015
Event Type  Death  
Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

 
Event Description

The representative from alere reported on (b)(6) 2015 that the patient received an error 7 on the coaguchek xs system. The caller was advised that the reported error 7 is a measurement error caused by the blood sample and it could mean an inr result that is higher than the meter measuring range (highest reading is 8. 0 inr) which would indicate a long coagulation time. The alere representative was told that an alternative test method should be sought. The alere representative acknowledged this information and stated they will have her tested in another way. Another alere representative called on (b)(6) 2015 and reported that the patient passed away that morning. The patient's daughter was contacted and stated her mom went to the hospital on (b)(6) 2015 and was admitted to the hospital due to internal bleeding. The patient did not receive medical treatment; she was transferred to hospice service because she was a do not resuscitate (dnr) patient, and passed away on (b)(6) 2015. No information regarding if or why not any lab result was sought on (b)(6) 2015. Her therapeutic range was 2. 0 inr to 3. 0 inr. 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 Key5057508
Report Number1823260-2015-04098
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 09/24/2015
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 Manufacturer08/26/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Unknown
Date Manufacturer Received08/11/2015
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
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