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); Device Issue (2379); Incorrect Or Inadequate Test Results (2456)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Patient self tester alleging unexpected inratio values.(b)(6) 2015 inratio = 1.1; repeat inratio = 2.1; (b)(6) 2015 inratio = 1.8.Patient's therapeutic range 2 - 3.No reported adverse patient sequela.

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house strip testing on the reported strip lot meets release criteria.The product performed as expected.A review of the manufacturing batch records for the reported strip lot did not uncover any non-conformances.The lot meets release specifications.The customer did not provide a laboratory comparative for the reported inratio value.It is not possible to verify if a discrepancy exists without this information.Although the root cause analysis did not include return testing, improper techniques were identified in the complaint.This could not be ruled out as a cause of the unexpected results.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Investigation/conclusion updated and corrected: the customer did not provide a laboratory comparative for the reported inratio values.It is not possible to verify if a discrepancy exists without this information.It is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house strip testing on the reported strip lot meets release criteria.The product performed as expected.A review of the manufacturing batch records for the reported strip lot did not uncover any non-conformances.The lot meets release specifications.Although a user issue was identified in the complaint, a root cause could not be determined.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 road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5231364
• MDR Text Key: 31691053
• Report Number: 2027969-2015-00939
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• 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: 367839A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: No
• 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