MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO/INRATIO2 TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100139

Device Problem Insufficient Information (3190)

Patient Problem Test Result (2695)

Event Date 01/31/2014

Event Type  malfunction  

Event Description

Caller alleged discrepant precision inratio inr results.Results are as follows: date: (b)(6) 2014, inratio inr: 4.9, 2.3, 1.8.All testing was performed within thirty minutes.Therapeutic range was not provided for the patient.There was no reported adverse patient sequels.There no was additional information provided.

Manufacturer Narrative

It is indicated that product is not returning for evaluation.Therefore, investigation of the complaint to determine root cause cannot be completed.Since the product associated with the complaint was not returned, retain testing was performed during an in-house investigation.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.Root cause could not be determined from the information provided by the customer.The manufacturing records for the lot were reviews.The lot met specification and no non-conformances were documented.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: INRATIO/INRATIO2 TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3850865
• MDR Text Key: 4618361
• Report Number: 2027969-2014-00107
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100139
• Device Lot Number: 300661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MEDICATIONS; WARFARIN; INRATIO MONITOR