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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 1000139
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Dehydration (1807); Weakness (2145); Complaint, Ill-Defined (2331)
Event Date 07/14/2014
Event Type  Injury  
Event Description
Caller alleged discrepant inratio inr result in comparison to the laboratory inr result.The time between testing was unk.Reportedly, the monitor was not in the correct mode when finger stick was performed and the first drop of blood was not used.The pt was hospitalized for weakness, dehydration and thrush.Patient was not eating or drinking since (b)(6) 2014.While in the emergency room, the inr was 11.6.The pt was administered vitamin k.There was no additional 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 Key4012988
MDR Text Key4689124
Report Number2027969-2014-00741
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/17/2014
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 Number1000139
Device Lot Number341996
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/28/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/17/2014
Initial Date FDA Received08/08/2014
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
ASPIRIN 81MG DAILY; WARFARIN 5-7MG DAILY; INRATIO MONITOR SN (B)(4); CIPRO 500MG X2 DAILY; FLUCONAZOLE 100MG DAILY; PANTOPRAZOLE 40MG DAILY; RANITONE 1MG DAILY; VASOTEC 5MG DAILY; MIRTAZAPINE 15MG DAILY
Patient Outcome(s) Required Intervention;
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