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

Model Number 100071

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 07/30/2014

Event Type  Injury  

Event Description

Alere received a report from an attorney of unspecified discrepant low inratio test results for one patient, one lot, one meter.Attorney is alleging patient hospitalized for internal bleeding and that the patient suffered injury as a result of the inratio meter/system.Date of hospital admission and date of discharge (if discharged) was not provided.Inratio result was reportedly compared to hospital lab results.Lab results, time between tests and date of lab result is unknown.Patient's therapeutic range unknown.Attorney is in possession of meter and test strips.Attempts were made to obtain additional information.To date, no additional information is available.

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 road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4135004
• MDR Text Key: 4942989
• Report Number: 2027969-2014-00865
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 09/02/2014

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: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/24/2014
• 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 Number: 1
• Treatment: INRATIO MONITOR, SERIAL # (B)(4)
• Patient Outcome(s): Hospitalization