MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 99007G1

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 12/24/2014

Event Type  malfunction  

Event Description

Caller alleged discrepant inratio results.Results as follows: date, inratio, lab: (b)(6) 2014, 6.8, -; (b)(6) 2014, 3.2, -; (b)(6) 2014, 1.8, 1.3; (b)(6) 2015, 4.8, 3.1.Time between tests on (b)(6) 2015: 15 minutes after inratio.Therapeutic range: 3-4.Customer also reports that his therapeutic range has been stable between 3.2 and 3.6.The patients previscan dose was decreased on (b)(6) from 1 to 1/2 for four days.On (b)(6) the inratio result was 3.2 and treatment was maintained at 1/2.On (b)(6) the patient presented with chest pain and shortness of breath; patient was hospitalized and given an injection of heparin.Patient stated he was "ok" and was released from the hospital.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

The customer reported a discrepant high inratio inr result during testing.It is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing data was performed.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.Impedance curve analysis was not performed because the meter associated with the complaint was not returned.A review of the manufacturing records for the lot did not uncover any non-conformances.Lot meets release specification.Root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

The following additional data was provided on (b)(6) 2015: date: (b)(6) 2015, inratio: 4.9, lab: 2.8.Lab test was taken 30 minutes after inratio test.

• Brand Name: INRATIO2 PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4521135
• MDR Text Key: 5354776
• Report Number: 2027969-2015-00112
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2015

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: 99007G1
• Device Lot Number: K352824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 02/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2015; 04/27/2015
• 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: INRATIO MONITOR: SERIAL # (B)(4); MEDICATION: PREVISCAN 1 PER DAY