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

Model Number 99008G2

Device Problem Low Readings (2460)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2014

Event Type  malfunction  

Event Description

Caller alleged discrepant low inratio2 inr result in comparison to the laboratory inr result.Both tests were performed simultaneously as a correlation.Therapeutic range was not provided for the patient.There was no adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO PT/INR TEST STRIP
• 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: 3807232
• MDR Text Key: 18304146
• Report Number: 2027969-2014-00256
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110212
• 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: 03/03/2014

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: Health Professional
• Device Model Number: 99008G2
• Device Lot Number: 324811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 03/19/2014
• 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: INRATIO2 PT/INR PRO MONITOR: SN (B)(4)