MAUDE Adverse Event Report: ALERE ALERE TEST STRIPS; PROTHROMBIN TIME TEST

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Since the purchase of my alere test strips and device in (b)(6) 2011, i was 100% dependent on them both for my pt/inr levels.My hematologist and pcp both depended on my home monitoring to obtain accurate results since i was taking a daily dose of 15 mg of warfarin to ward off a 7th dvt.Both physicians were stumped by the fact that i reported consistently low readings between.08 - 1.09 yet i assured them i was taking the 15 mg daily.Bottom line once again is: don't trust anyone, anything, anywhere.I should have just been having the test done in the lab rather than risking my life.Alere is responsible to refund all my money.I don't want any more of their defective products.I wish i had real lab tests to show you.

• Brand Name: ALERE TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE
• MDR Report Key: 3829851
• MDR Text Key: 19299763
• Report Number: MW5036191
• Device Sequence Number: 1
• Product Code: GJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/18/2014

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 52 YR
• Patient Weight: 91