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); Incorrect Or Inadequate Test Results (2456)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio value.Patient's therapeutic range 2.5 - 3.0.(b)(6) 2016 inratio inr = 3.4; lab inr = 2.7 (tests performed 5.5 hrs apart).(b)(6) 2016 inratio inr = 3.9; (b)(6) 2016 lab inr = 1.9 physician recommended holding coumadin dose on both (b)(6) 2016 after obtaining inratio results.

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 testing on the reported strip lot met 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 specification.Although an improper technique was identified in the complaint, the root cause of the customer's complaint 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: 5638774
• MDR Text Key: 44696813
• Report Number: 2027969-2016-00305
• 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: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 373678A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR