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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 04625315160
Device Problem Device Displays Incorrect Message
Event Date 11/03/2015
Event Type  Malfunction  
Event Description

The first nurse from the home health facility called about obtaining an error 5 and error 6 on the patient while attempting to test with the coaguchek xs (serial number (b)(4)). The nurse was assisted to run a test while on the phone with the company agent and a result of 5. 8 inr was obtained. She had no further questions about the result or the meter. A second nurse called back and reported obtaining an error 5 with the same patient on the same meter. The company agent then assisted the second nurse to test the patient again and a result of 7. 7 inr was obtained 15 minutes after the result of 5. 8 inr. The same vial of strips and different fingers were used for the results. It was reported that the inr result for the patient was high. The patient was sent to the hospital to test the inr with the lab. A lab result of 3. 0 inr was obtained an hour or so after the 7. 7 inr result. The nurse does not know if the lab uses the dade innovin reagent. The patient was not admitted to the hospital and no treatment was received. She is currently feeling "okay". It is reported that no changes were made to the customer's medication. The patient is not on heparin, is not anemic and does not have any antiphospholipid antibodies. It was reported that the patient has not had any special or unusual diet. The patient last took 2. 5 mg warfarin in the morning of (b)(6) 2015. The qc check was seen while running the tests. There was no adverse event.

 
Manufacturer Narrative

Relevant retention test strips (lot 29392512) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 230734-80) no error messages occurred. Retention samples were acceptable.

 
Manufacturer Narrative

The suspect product was not returned. No further information available at this time.

 
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Brand NameCOAGUCHEK ® XS SYSTEM
Type of DevicePROTHROMBIN 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) 68305
GM  68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis , IN 46250
3175214343
MDR Report Key5243189
Report Number1823260-2015-04620
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date09/30/2016
Device Catalogue Number04625315160
Device LOT Number29392512
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location AMBULATORY Health CARE Facility
Date Manufacturer Received11/03/2015
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

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