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MAUDE Adverse Event Report

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HEMOSENSE, SJ INRATIO PROTHROMBIN TIME TEST   Back to Search Results
Model Number HIT, PROFESSIONAL USER, ENGLISH
Event Date 01/14/2008
Event Type  Malfunction  
Event Description

Caller alleges inaccuracy with inratio. Results as follows: date: early 2007. Inratio: 2. 1. Lab: 8. 5.

 
Manufacturer Narrative

Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: early 2007, inratio: 2. 1, lab: 8. 5, mean: 5. 3, confidence limits: unable to be determined. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. The confidence limits cannot be determined. The readings are considered inaccurate based on "area outside the acceptance region" table. The results are considered discrepant within the context of the documented variability for inr testing. Therefore, further testing is required at this time. In troubleshooting found that the pt has antiphospholipid antibody syndrome. It was explained that possible interferences may be due to the varying levels of the antibodies. Pts condition may cause the discrepant errors.

 
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Brand NameINRATIO
Type of DevicePROTHROMBIN TIME TEST
Manufacturer (Section D)
HEMOSENSE, SJ
san jose CA
Manufacturer Contact
651 river oaks parkway
san jose , CA 95134
(408) 240 -3800
Device Event Key993363
MDR Report Key992049
Event Key951182
Report Number2954730-2008-00040
Device Sequence Number1
Product CodeJPA
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Other
Type of Report Initial
Report Date 01/14/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Device EXPIRATION Date10/31/2008
Device MODEL NumberHIT, PROFESSIONAL USER, ENGLISH
Device LOT Number070472
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/14/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

 
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