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

Model Number 100071

Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

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

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.

Event Description

The caller (end user) alleged a variance between the inratio inr result and the laboratory inr result.Results are as follows: date: (b)(6) 2016, inratio inr: 2.4, laboratory inr: 5.4.Therapeutic range: 2.0 - 3.5.The time between testing was one (1) hour.The caller reported that the finger was "milked" after the finger stick.This is considered to be an improper technique when performing the inratio test.Additionally, the caller reported taking the antibiotic, macrobid, for bladder infection.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the in-house testing history of the lot was performed.In-house testing on strip lot 378740a met release criteria and the product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer was identified as using improper technique and having a condition (bladder infection) that may impact the performance of the assay.Patient sample interference could not be ruled out as a cause for the unexpected result.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• 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 (Section G): 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: 5417186
• MDR Text Key: 38173318
• Report Number: 2027969-2016-00081
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• 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: 378740A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• 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