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); Improper or Incorrect Procedure or Method (2017); Low Test Results (2458)

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

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

A variance between inratio inr and lab inr results was reported.The results were as follows: (b)(6): inratio=1.8, lab=2.5 (testing one hour apart).(b)(6): inratio=2.1, lab=2.9 (testing one hour apart).The reported therapeutic range was: :2.5-3.5.It was reported that finger was being milked after the fingerstick.Patient was taking antibiotics for a urinary tract infection starting on (b)(6) 2016 (levofloxacin (500 mg/day; started (b)(6), stopped (b)(6)) amoxicillin (500 mg x3/day; started on (b)(6) to present).

Manufacturer Narrative

The product was not returned for evaluation.Therefore, a review of the entire testing history for the reported lot was performed.In-house testing on strip lot 376826a meets release criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any non-conformances; the lot met release specifications.It was reported that the customer is taking antibiotics for a urinary tract infection.Certain medications or health conditions, such as antibiotics and bacterial infections, may affect the action of oral anticoagulants and impact the performance of the assay.Although a technique issue and a potential patient sample interference were identified in the complaint, a root cause could not be determined with 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.

• 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: 5692894
• MDR Text Key: 47603675
• Report Number: 2027969-2016-00412
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

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
• Device Lot Number: 376826A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• 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