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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 100071
Device Problem Low Test Results (2458)
Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Event Date 01/10/2014
Event Type  Injury  
Event Description
"caller alleged discrepant results compared with the lab.Results as follows:" date: (b)(6) 2014, inratio2: 3.1, lab: 24.8.Testing performed three hours apart.Therapeutic range 2-3.Pt was admitted to the hospital on (b)(6) 2014 with low blood pressure and o2 levels.Pt was treated with vitamin k and plasma.
 
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 summer ridge rd
san diego, CA 92121
8588052084
MDR Report Key3677414
MDR Text Key17987321
Report Number2027969-2014-00188
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,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/12/2014
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 Lay User/Patient
Device Model Number100071
Device Lot Number329655
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/04/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/12/2014
Initial Date FDA Received03/06/2014
Was Device Evaluated by Manufacturer? Yes
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
OTHER MEDICATIONS FOR LOW THRYOID (TYPE AND DOSE U; ORAL ANTICOAGULATNS COUMADIN
Patient Outcome(s) Hospitalization; Required Intervention;
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