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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 09/12/2015
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

The patient reports being unable to obtain an inr result due to an error on the coagucheck xs system. Two days later the patient went to the hospital because of heavy bleeding; her result at the hospital was 6. 1 inr and she was treated with an injection of vitamin k, and released home the following day. Requested return of suspect system and replacement was sent.

 
Manufacturer Narrative

It was not possible to investigate this issue, because the customer material was not returned and the used lot-no. Is unknown.

 
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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 Key5145066
Report Number1823260-2015-04326
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 12/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2015
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? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Unknown
Date Manufacturer Received09/15/2015
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
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/13/2015 Patient Sequence Number: 1
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