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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2; PROTHROMBIN TIME TEST
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ALERE SAN DIEGO, INC. INRATIO2; PROTHROMBIN TIME TEST Back to Search Results
Model Number 99008G2
Device Problem High Test Results (2457)
Patient Problems Hematoma (1884); Loss of consciousness (2418)
Event Date 01/21/2014
Event Type  Injury  
Event Description
Caller alleged discrepant inratio2 results.Results as follows: inratio: 4.6, lab: 12.Time between tests: 5 hours.Therapeutic range: 2-3.Pt had a steroid injection before testing on the inratio meter.Pt developed a hematoma on the spine where the steroid was injected.Pt went to er because she passed out, and is currently in critical condition.Customer called back on (b)(6) 2014 to state that the pt was given vitamin k therapy and was transferred to a nursing home.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
INRATIO2
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 Key3672013
MDR Text Key4340937
Report Number2027969-2014-00127
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number99008G2
Device Lot Number330238
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/10/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2014
Initial Date FDA 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
Patient Outcome(s) Other;
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