MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR PROFESSIONAL TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 99008G1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Hematoma (1884); Overdose (1988)

Event Date 06/08/2014

Event Type  Injury  

Event Description

Caller alleged discrepant inratio results.Results as follows: pts inr was measured on (b)(6) during a home visit using the inratio2 with a result of 2.30 inr.Pt had hematoma's on both arms.A venous blood sample was drawn, refrigerated and transported to the lab on (b)(6); inr result = greater than 8.Since the pt had hematoma's on both arms, a venous blood sample was additionally taken on (b)(6) and brought to (b)(6).The lab test result was 17.32 inr.The pt was hospitalized in (b)(6) with abdominal pain on (b)(6) 2014.Eba inr= greater than 8.Pt presented with aqueous diarrhea and strong pain in the whole abdomen.In addition, the pt had numerous hematoma's at the extremities.The pt was treated for non specific abdomen, and also given beriplex 2000ie due to an oral anti-coagulation overdose.Therapeutic range: 2.0-3.5.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL 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: 4081156
• MDR Text Key: 16540728
• Report Number: 2027969-2014-00817
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2014

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: 99008G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2014
• Initial Date FDA Received: 09/05/2014
• 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 NUMBER: (B)(4); MEDICATION: MARCUMAR
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR