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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST
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ALERE SAN DIEGO, INC INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST Back to Search Results
Model Number 100071
Device Problems Device Expiration Issue (1216); Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2014
Event Type  malfunction  
Event Description
Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.Results are as follows: date:(b)(6) 2014; inratio inr: 2.0; laboratory inr: 6.0; the time between testing was within 3 hours.Reportedly, the strips were past their expiration date.Therapeutic range 2.0-3.0 for the pt.There was no reported adverse pt sequela.There was no add'l info provided.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
INRATIO PT/INR 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 Key4258722
MDR Text Key5109803
Report Number2027969-2014-00808
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 08/11/2014
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 Number315108
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/12/2014
Initial Date FDA Received09/03/2014
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
INRATIO MONITOR SN: (B)(4)
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