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

Model Number 100071

Device Problems False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Burning Sensation (2146); Dizziness (2194); Anxiety (2328); Palpitations (2467); Ambulation Difficulties (2544)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

A letter was received from a patient self tester who stated that she had been using the inratio test and observing discrepant results for four months in 2014.No actual results were provided.Customer stated "because of the readings, i was adjusting my blood thinner medication at home.I suffered severe dizziness, heart palpitations, anxiety, stress, burning sensations in my neck, face and ears, chronic stomach issues and was also very unbalanced in walking.I assumed it was due to my blood not being on scale and my medications needing to be adjusted.This lasted for approximately 4 months prior to my contacting my physician.I went into his office twice during this time and had my blood checked there and it was always off from the home monitor.I had increased and decreased and occasionally skipped taking my blood thinners for 4 months.All the while getting billed and paying for supplies that were giving me false readings and could have cost me more severe medical issues or even death.I have an extensive medical background.I have had pulmonary embolisms in both of my lungs, a brain tumor, excessive bleeding, gall bladder removed, high blood pressure, thyroid disease, to name some.".

Manufacturer Narrative

No strip lot number or inratio monitor serial number was provided by the customer, therefore, further investigation cannot be performed and root cause cannot be determined.Based on the information provided, there is no evidence of product deficiency.No corrective action is required at this time.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4682392
• MDR Text Key: 22068730
• Report Number: 2027969-2015-00263
• 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: Patient
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/10/2015
• 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: BLOOD PRESSURE MEDICATION; THYROID MEDICATION; BLOOD THINNERS