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); High Test Results (2457); Device Displays Incorrect Message (2591)

Patient Problems Misdiagnosis (2159); No Consequences Or Impact To Patient (2199)

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

The caller alleged a variance between the inratio inr result in comparison to the lab/poc inr result.The results were as follows; (b)(6) unsure if lab or poc=4.8, (b)(6) inratio=4.0, (b)(6) inratio=1.4, (b)(6) lab=2.7.Patient self tester's therapeutic range: 2.0-3.0.The patient self tester went to the physician's office on (b)(6) and had his inr tested, inr=4.8.Wife was unsure if the result was obtained through a poc meter or a laboratory method.No dosage changes were made because the physician did not agree with the result.On (b)(6) patient tested on his monitor with result of inratio inr=4.0.This result was reported to physician and dosage was changed.Testing was done on (b)(6) with inratio=1.4; physician had patient self tester increase dosage however wife does not remember how much of an increase.On (b)(6) the patient self tester attempted to retest again and received 2 error messages (for not enough sample); no dosage changes were made.On (b)(6) a lab test was performed with an inr=2.7.Using the venous blood testing was done on the inratio monitor with qc2h error message.

Manufacturer Narrative

It is indicated that the product is not returning for evaluation.Therefore, a review of the in-house testing history was performed.In-house testing on strip lot 369157a met release criteria.The product performed as expected.A review of the manufacturing records for lot# 369157a did not uncover any non-conformances.The lot met release specifications.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.

• 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: 5057773
• MDR Text Key: 25785552
• Report Number: 2027969-2015-00650
• 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: 08/11/2015

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
• Device Lot Number: 369157A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2015
• Initial Date FDA Received: 09/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• 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