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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Underdose (2542); Test Result (2695)

Event Date 05/27/2014

Event Type  Injury  

Event Description

Called alleged discrepant inratio results.Results as follows: venous lab draw was taken as part of routine procedure at chemotherapy clinic on (b)(6) 2014.Pt was sent home and the nurse forgot to administer vitamin k.Inratio test was performed 2.5 hours later after pt was informed the nurse forgot to administer vitamin k.Therapeutic range: 2.5-3.5.(b)(6) 2014: coumadin dose was lowered to 5mg.(b)(6) 2014: coumadin dose was held due to lab result.Pt self tester was admitted to the emergency room on (b)(6) 2014 with a high inr.Pt was administered oral vitamin k and discharged (b)(6) 2014.No report of bruising or bleeding.

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: 3931527
• MDR Text Key: 4579499
• Report Number: 2027969-2014-00599
• 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: 05/29/2014

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: 335798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 06/20/2014
• 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: GEMZAR,; INRATIO MONITOR SERIAL (B)(4); MEDICATIONS: COUMADIN 6MH/DAY,; OXYCODONE
• Patient Outcome(s): Required Intervention