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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO; PROTHROMBIN TIME TEST
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ALERE SAN DIEGO, INC. INRATIO; PROTHROMBIN TIME TEST Back to Search Results
Model Number 100071
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problems Pain (1994); Hematuria (2558)
Event Date 02/10/2014
Event Type  Injury  
Event Description
Caller alleged discrepant inratio results.Results as follows.Cannot confirm origin of results (lab, poc, inratio).Results from inratio meter memory.Therapeutic range: 2-3.(b)(6) 2014: coumadin held; resumed on (b)(6) at 1mg/dat.(b)(6) 2014: coumadin held; began taking 1mg every other day on (b)(6).Dose change based on inr result from (b)(6) 2014.Pt self tester went to the emergency room on (b)(6) 2014 with stomach pains, blood in urine and not feeling well.A cat scan was performed with clear results.He received vitamin k treatment and his coumadin does was altered.
 
Manufacturer Narrative
Pending investigation.
 
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Brand Name
INRATIO
Type of Device
PROTHROMBIN TIME TEST
Manufacturer (Section D)
ALERE SAN DIEGO, INC.
san diego CA
Manufacturer Contact
ya-ling king
9975 summers ridge rd
san diego, CA 92121
8588052084
MDR Report Key3830188
MDR Text Key4501838
Report Number2027969-2014-00217
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number100071
Device Lot Number315108
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/11/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/14/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
COUMADIN (1MG EVERY OTHER DAY); ADDERALL (A COUPLE TIMES A MONT)
Patient Outcome(s) Other;
Patient Age24 YR
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