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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMOSENSE, INC. INRATIO PROTHROMBIN TIME TEST

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HEMOSENSE, INC. INRATIO PROTHROMBIN TIME TEST Back to Search Results
Lot Number 060656
Event Date 01/22/2007
Event Type  Malfunction  
Event Description

Caller alleged discrepant results compared with the lab. Results as follows: date: 01/05/07, inratio: 6. 1, lab: 3. 8. Date: 01/15/07; inratio: 4. 3; lab: 2. 8. Pt has antiphospholipid antibody syndrome (cardiolipin-positive, lupus-negative).

 
Manufacturer Narrative

Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: 01/05/07, inratio: 6. 1, lab: 3. 8, mean: 4. 95, confidence limits: 2. 8-7. 2. Date: 01/15/07, inratio: 4. 3, lab: 2. 8, mean: 3. 55, confidence limits: 2. 2-5. 3. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. Both inratio and lab values are within the confidence limits for inr testing. The results are not considered discrepant within the context of the documented variability for inr testing. Therefore, further testing is not required at this time. Per text "pt has antiphospholipid antibody syndrome, (cardiolipin-positive, lupus-negative). " pt's condition may be causing interference.

 
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Brand NameINRATIO
Type of DevicePROTHROMBIN TIME TEST
Manufacturer (Section D)
HEMOSENSE, INC.
san jose CA 95134
Manufacturer Contact
651 river oaks parkway
san jose , CA 95134
4082403800
MDR Report Key827524
Report Number2954730-2007-00072
Device Sequence Number1
Product CodeJPA
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 02/09/2007
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date01/31/2008
Device LOT Number060656
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/22/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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