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

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problems Cellulitis (1768); Erythema (1840); Pain (1994); Swelling (2091); Toxicity (2333)

Event Date 09/07/2014

Event Type  Injury  

Event Description

Caller alleging discrepant low inratio value.Time between inratio value and lab results 13 days.Patient's therapeutic range 2-3.Patient self tester was admitted to the hospital on (b)(6) 2014 3:35 p.M.For cellulitis of right leg and coumadin toxicity.Pain, swelling and redness of leg.No bleeds or bruising noted.Two bags of fresh frozen plasma and two vitamin k pills administered to decrease high inr.Other medications administered were clindamycin and phytonadione.First lab inr was conducted at 4:07 p.M.With a result of 12.7.Second lab inr was conducted at 5:08 p.M.Result 14.22.Exact reference method unknown.Patient discharged at 11:30 p.M.On (b)(6) 2014.Discharge diagnosis cellulitis of the leg and coumadin toxicity.No inr taken upon discharge.Patient in stable condition upon discharge.Patient to follow up with clindamycin (300 mg) at home and follow-up with doctor.

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: 4143981
• MDR Text Key: 4913901
• Report Number: 2027969-2014-00903
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/23/2014

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: 341994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/02/2014
• 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: TABLET 1 TAB/MORNING; VERAPAMIL (120 MG TABLET 1X/DAY), 240 MG/12 HRS,; TORSEMIDE (2 MG TABLET, 1 TAB/DAY); ALBUTEROL (2 PUFFS 4X/DAY AS NEEDED); LISINOPRIL (10 MG TABLET, 1 TAB/DAY); BUDESONIDE-FORMOTEROL (2 PUFFS 2X/DAY AS NEEDED); WARFARIN (3 MG (B)(6), 5 MG (B)(6)); DIGOXIN (125 MG TABLET, 1 TAB/DAY); ROSUVASTATIN (10 MG TABLET, 1 TAB/DAY); INRATIO MONITOR, SERIAL # (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention