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

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); Dyspnea (1816); Pneumonia (2011)

Event Date 12/13/2015

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

The caller alleged a variance between inratio inr results and the lab inr results.The results were as follows: (b)(6) 2015: lab inr = 8.0.(b)(6) 2015: subsequent inr2 result = 1.3.The patient self tester's therapeutic range is: 2.0-3.0.The patient self tester and (b)(6) (relationship not provided) called to report discrepant low inratio results.Patient self tester has been testing with inratio since 2009 and historical results have been within his therapeutic range of 2.0-3.0.No adverse event was reported - no bleeding/bruising.On the morning of (b)(6), the patient self tester presented to the hospital with shortness of breath, congested sinuses and was informed of slight fluid in his lungs; he was admitted for pneumonia; the lab draw resulted in inr=8.0 upon admission.His warfarin was stopped upon admission.During hospitalization from (b)(6), the patient self tester was administered antibiotic i.V.On (b)(6) his inr result in the hospital was 6.0.Patient self tester was discharged (b)(6) with a course of oral antibiotics (clindamycin 300 mg 3x/day).(b)(6) was the patient self tester's last dose of warfarin prior to hospitalization.Discharge instructions from physician included an office visit appointment on (b)(6); the physician's meter (brand not known) resulted in inr= 2.1.Patient self tester's warfarin was resumed (b)(6) at dosing of 4mg.The patient self tester obtained inratio result =1.3 on (b)(6); he is still on oral clindamycin.

Manufacturer Narrative

Only the meter associated with the complaint was returned for investigation; no test strips were provided.The customer's complaint was not replicated.Retain strip testing on the returned meter meets criteria.A review of the entire testing history for lot 376826a was performed.In-house testing on strip lot 376826a meets release criteria.The product performed as expected during in-house investigation.Functional and thermistor testing were performed on the returned meter with passing results.The manufacturing records for the lot 376826a were reviewed and did not uncover any non-conformances.The lot meets release specification.The impedance curve for the customer's result of 1.3 was statistically analyzed and was concluded to be normal in shape.Based on the information available, there is no indication of a 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: 5361641
• MDR Text Key: 35733778
• Report Number: 2027969-2016-00020
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 12/19/2015

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: 376826A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2015
• Initial Date FDA Received: 01/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization