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

Model Number 99008G2

Device Problem Low Test Results (2458)

Patient Problems Hemorrhage/Bleeding (1888); Test Result (2695)

Event Date 01/14/2014

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory result.Results are as follows: date: (b)(6) 2014, inratio inr: 3.0, laboratory inr: 11.0.Therapeutic range was 2.0 - 3.0 for the pt.The time between testing was 3-4 hours and no medications were taken between the two tests.The pt was hospitalized on (b)(6) 2014, with bleeding colitis.Reportedly, the pt had a history of diarrhea prior to the testing.Treatment included intravenous (iv) fluids and the holding of warfarin.No blood products were administered.Any additional treatment is unk.As of (b)(6) 2014, the pt remained hospitalized.Though requested, additional information has not been provided.

• 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: 3649956
• MDR Text Key: 19324491
• Report Number: 2027969-2014-00101
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/15/2014

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: 99008G2
• Device Lot Number: 331340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 02/07/2014
• 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: DOCUSATE SODIUM; WARFARIN 5MG 4 DAYS/WEEK; IMODIUM AD 2MG; INRATIO 2 MONITOR SN (B)(4); VIT D 3 4000 UNITS; GLUCOSAMINE CHONDROITIN; ENSURE ORAL LIQUID ENS; ALAVERT 10MG DAILY; WARAFARN 6MG 3 DAYS/WEEK; ATORVASTATIN 20 MG DAILY
• Patient Outcome(s): Hospitalization; Required Intervention