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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
Model Number XS PST
Device Problem Expiration Date Error
Event Date 08/28/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

The customer complained of erroneous inr results on coaguchek meter with serial number (b)(4). The customer initially tested on the meter and obtained a result of 6. 2 inr at 9:00 a. M. The customer reported this result to her healthcare provider. The customer discovered that she was using expired test strips at the time of this result. The customer alleged that the meter did not produce an error message at the time of the erroneous result while using expired strips. The customer stated the time and date was set correctly and she was using the correct code key at the time of the 6. 2 inr result. The customer switched to a new, non-expired vial of test strips and re-tested on the meter using a different finger at 10:00 a. M. And obtained a result of 1. 8 inr. This result was also reported to the customer¿s healthcare provider. The customer re-tested again using another different finger at 10:30 a. M. And obtained a result of 1. 8 inr. The customer and her doctor believe the result of 1. 8 inr was correct. The customer¿s therapeutic range is 2. 0 3. 5 inr. No adverse event occurred. The customer feels ok. The new, non-expired test strip lot number was 15288123 with an expiration date of 28-feb-2018. The meter has never been cleaned. The customer has no hct issues and does not have antiphospholipid antibodies. The customer¿s coumadin dose has not been changed nor has her diet changed. She has bruises frequently and sometimes bleeding, however, no medical treatment has been necessary. The meter and test strips were requested for investigation; however, neither strip vial is available for return. Relevant retention test strips (lot 152881-23) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 124158-80). For this purpose two human blood samples from marcumar donors and two internal reference meters were used. No error messages occurred. Retention material was acceptable.

 
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Brand NameCOAGUCHEK ® XS SYSTEM
Type of DevicePROTHROMBIN TIME MONITOR
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 Key6869298
Report Number1823260-2017-02005
Device Sequence Number1
Product CodeGJS
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup,Followup
Report Date 12/11/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberXS PST
Device Catalogue Number04837738001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2017
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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