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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 060452
Event Date 01/11/2007
Event Type  Malfunction  
Event Description

Caller alleged discrepant results compared with the lab. Results as follows: date: 01/12/07, inratio: 6. 1, lab: 3. 6. Ts updated this case on 01/18/2007 and 01/19/2007. 01/17/07, first test inr = 7. 5(old strip). Second test inr = 5. 5(new strip). Date: 01/19/07, inratio: 6. 5, lab: 4. 0. Caller has antiphospholipid antibody syndrome and recently had an episode of multi organ infection resulting in failure of adrenal glands.

 
Manufacturer Narrative

Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: 01/12/07, inratio: 6. 1, lab: 3. 6, mean: 4. 85, confidence limits: 2. 8-7. 2. Per internal procedure, the mean of the inratio meter an 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. Ts updated this case on 01/18/2007. Inratio precision data provided by end-user lot 060452: 01/17/07 first inr = 7. 5(old strip). Second test inr = 5. 5 (new strip), mean = 6. 5; sd = 1. 4; %cv = 21. 7%. The %cv is grater than 20%. Per internal procedure, the precision failed the criteria for precision. Products will be tested. Ts updated this case on 01/19/2007. Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: 01/19/07, inratio: 6. 5, lab: 4. 0, mean: 5. 25, confidence limits: cannot be determined. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. The confidence limits for inr testing cannot be determined. The mean was > 5. 0 and the difference between inr's >2. 2. The comparison was considered inaccurate. Products will be tested.

 
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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 Key812419
Report Number2954730-2007-00039
Device Sequence Number1
Product CodeJPA
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 01/22/2007
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/26/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date10/31/2007
Device LOT Number060452
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/11/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2006
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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