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

Model Number 100071

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017); Low Test Results (2458)

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

Event Date 03/06/2015

Event Type  malfunction  

Event Description

Patient self tester's daughter called reporting an unexpected low result with inratio-1.3 on (b)(6) 2015.Additional results were supplied by the distributor as follows: (b)(6).The patient self tester's therapeutic range is: 1.8-2.6.The monitor was on the arm of a chair during testing.The monitor was not in the correct mode when finger stick was performed; milking of the finger occurred.

Manufacturer Narrative

The customer did not provide any reference values for comparison.The accuracy of the customer's inratio results cannot be determined without this information.It is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.Retain strip testing results met both accuracy and strip repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot did not uncover any relevant non-conformances.The lot meets release specification.A technique issue and two user issues were identified in the complaint.These cannot be ruled out as causes for the unexpected results.Root cause is unable to be determined from the information provided.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: 4662430
• MDR Text Key: 5730364
• Report Number: 2027969-2015-00247
• 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
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• 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: 357499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2015
• 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: WARFARIN; INRATIO MONITOR SN: (B)(4)