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

Model Number 100071

Device Problem Low Readings (2460)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2014

Event Type  malfunction  

Manufacturer Narrative

The original submission was inadvertently submitted under emdr 2027969-2014-01607.This filing is to correct the error and file the initial report under the correct emdr 2027969-2014-01067.Investigation/conclusion: it is indicated that 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 repeatability criteria.The products performed as expected, and no product deficiencies were observed.The manufacturing records for the lot were reviewed, and there were no issues related to this complaint.Customer did not provide a lab reference value for comparison.Unable to determine the accuracy of the in ratio results without this information.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Caller alleged discrepant low in ratio inr results.Results are as follows: date: inratio inr.On (b)(6) 2014, at 0.9 and 2.1.The time between testing was two (2) minutes.Reportedly, patient is only concerned with inratio 0.9 result.Therapeutic range 2.0 - 3.0 for the patient.There was no additional information provided.

• 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: monika burrell ; 9975 summers ridge road; san diego, CA 92121 ; 8588052506
• MDR Report Key: 4298464
• MDR Text Key: 220771855
• Report Number: 2027969-2014-01067
• 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
• Report Date: 11/24/2014

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: 354045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/04/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female