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)

Patient Problems Headache (1880); No Consequences Or Impact To Patient (2199)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

The caller alleged a variance between the inratio inr result in comparison to the lab inr result.The results are as follows: (b)(6): inratio= 3.0, lab= 0.9.Patient self tester's therapeutic range is: 2.0-3.0.On (b)(6) 2015 the patient self tester experienced a severe headache and took ibuprofen for the pain.The following day the headache was severe and patient self tester decided to go to the emergency room.About 1.5 hours after getting an inratio=3.0 the lab inr=0.9 at the er.Because of the headache and mri was performed and results were negative.The patient self tester was not admitted and was sent home following the mri results; she was not given any treatment and no changes were made to medications.

Manufacturer Narrative

It is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history was performed.In-house testing on strip lot 369157a meets release criteria.The product performed as expected.A review of the manufacturing records for lot# 369157a did not uncover any non-conformances.The lot meets 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: 5092326
• MDR Text Key: 26603679
• Report Number: 2027969-2015-00690
• 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: Followup
• Report Date: 08/26/2015

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: Not provided
• Initial Date FDA Received: 09/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• 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