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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO/INRATIO2 TEST STRIPS; PROTHROMBIN TIME TEST
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ALERE SAN DIEGO, INC. INRATIO/INRATIO2 TEST STRIPS; PROTHROMBIN TIME TEST Back to Search Results
Model Number 100071
Device Problem Imprecision (1307)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2014
Event Type  malfunction  
Event Description
Caller alleged discrepant precision inratio2 inr results.Results are as follows: date: (b)(6) 2014, inratio2inr: 5.3, 1.0, and 4.2.The time between testing was within minutes.Therapeutic range was not provided for the patient.There was no reported adverse patient sequela.There was no additional information provided.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
INRATIO/INRATIO2 TEST STRIPS
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 Key3727149
MDR Text Key4325388
Report Number2027969-2014-00053
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 01/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number100071
Device Lot Number331424
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/03/2014
Initial Date FDA Received01/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
SN #(B)(4); COUMADIN, ALERE INRATIO 2 PT/INR PST MONITOR
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