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

Model Number 100071

Device Problem High Test Results (2457)

Patient Problems Hemorrhage/Bleeding (1888); Hematuria (2558)

Event Date 07/07/2014

Event Type  Injury  

Event Description

"caller alleged discrepant results compared with the lab.Results as follows:" date: (b)(6) 2014, inratio: 2.9, repeat 2.9, lab: 19.2.Time between tests: a few minutes between the two inratio tests; lab was performed within 2.25 hours.Therapeutic range: 2-3.Patient woke up with a nosebleed.She checked her inr with her inratio and had a result of 2.9 twice.The patient's doctor recommended she go to the hospital due to the bleeding.The lab inr = 19.2 when tested in the er.Patient was admitted due to hematuria, bleeding from gums and nose.Patient was given 10mg of vit.K and 2 units of fresh frozen plasma (ffp).Upon admittance the lab inr = 3.2; hct = 46.7%; hgb = 15.5.The following day ((b)(6) 2014) the patient was given additional 2 units of ffp; lab inr = 1.9.On (b)(6) 2014 lab inr = 1.5.Nurse stated patient is currently stable and is waiting for her inr to drop below 1.5 for cystoscopy with bilateral rpg and uroscopy.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3987507
• MDR Text Key: 19588364
• Report Number: 2027969-2014-00705
• 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: 07/07/2014

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: 07/07/2014
• Initial Date FDA Received: 07/25/2014
• 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: DOLOPHINE, 10 MG TABLET, EVERY 8 HRS AS NEEDED; VICODIN, EVERY 6 HOURS AS NEEDED; DITROPAN XL, 10 MG DAILY; COUMADIN - ON HOLD STARTING; LASIX, 20 MG TABLET DAILY; MONITOR SN: (B)(4); METOPROLOL, 300MG DAILY; LIPITOR, 10MG TABLET DAILY; NORCO, EVERY 6 HOURS AS NEEDED
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR