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

Model Number 100071

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problems Transient Ischemic Attack (2109); Confusion/ Disorientation (2553)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The caller alleged a variance between the inratio inr result and the laboratory inr result.On (b)(6) 2015 at 10:47am, the caller tested on the inratio device and her inr was 2.2.The caller's therapeutic range was 2.5 - 3.5.She takes her warfarin in the evening and had taken her normal dose the night before.On (b)(6) 2015 at 11:59 am, the caller's inratio inr was 2.3.The caller was driving with her daughter when she experienced confusing speech and was admitted to hospital.Her daily warfarin had not yet been taken.The laboratory inr at 12:30pm was 1.4.A computerized tomography (ct scan) was performed and the caller was diagnosed with a transient ischemic attack (tia).Treatment included a heparin drip and oral coumadin.On (b)(6) 2014, the caller was discharged from the hospital with an laboratory inr of 2.5.Warfarin dose was 5mg 5 days and 2.5mg 2 days.On (b)(6) 2015, the caller followed up with her physician however no laboratory inr was performed.On (b)(6) 2015 at 9:55 am, the inratio inr was 2.3.The warfarin dose was 5mg 6 days and 2.5mg 1 day.There was no additional information provided.

Manufacturer Narrative

It is indicated that the product is not returning for evaluation.Therefore, a review of the testing history on lot 373678a was performed and met release criteria.The product performed as expected.A review of the manufacturing records for lot 373678a did not uncover any non-conformances and the lot met release specification.The customer reported a history of skin cancer, colon cancer and colitis.These conditions may impact the performance of the assay.An improper technique was identified in the complaint.This cannot be ruled out as a cause for the unexpected results.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5278413
• MDR Text Key: 33052387
• Report Number: 2027969-2015-00995
• 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: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• 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: 373678A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2015
• 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: OTHER UNSPECIFIED MEDICATIONS
• Patient Outcome(s): Hospitalization; Required Intervention