MAUDE Adverse Event Report: ALERE SAN DIEGO INC INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100139

Device Problems Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017); Low Test Results (2458)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/22/2014

Event Type  Injury  

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.Lab inr: 6.8.Therapeutic range: 2.0-3.0.The pt was treated on the inratio device in the am.The inratio monitor was on a "flamsy" bedside tray and the operator states that the tray may have been bumped during testing.Additionally, the monitor was not in the correct mode when the finger stick was performed and the finger was "milked" after the finger stick.Later in the day, the pt experienced unspecified nose and throat bleeding and visited the er that evening.The pt was subsequently hospitalized.Treatment included holding their coumadin for a few days and vitamin k.Though requested there was no additional info provided.

Manufacturer Narrative

Investigation pending.

• 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 Key: 4193244
• MDR Text Key: 5097194
• Report Number: 2027969-2014-00942
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2014

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 Number: 100139
• Device Lot Number: 350589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/17/2014
• 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 Number: 1
• Treatment: INRATIO MONITOR SN (B)(4); COUMADIN
• Patient Outcome(s): Hospitalization; Required Intervention