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

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/27/2014

Event Type  Injury  

Event Description

Caller alleged discrepant inratio results.Results as follows: date: (b)(6), inratio: 2.2, lab: -; 04/30, -, >10 (on admission to hospital).Therapeutic range: 2.0 - 3.0.On (b)(6): patient had a gi bleed.On (b)(6): pt was still bleeding; went to the hospital where he received vitamin k treatments and his warfarin was held.Heparin was started in the hospital.Pt self tester stayed on heparin until (b)(6) when he was transitioned back to warfarin and released on (b)(6).Caller reports the following: inratio monitor not in correct mode when finger stick was performed, milking finger stick, and monitor was held in his hand white testing.

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: 3949321
• MDR Text Key: 4601994
• Report Number: 2027969-2014-00647
• 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: Consumer,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/16/2014

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
• Device Lot Number: 334579
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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: PAIN MED, ABX STARTED END OF APRIL; WARFARIN; INRATIO MONITOR (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention