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

Model Number 100139

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2013

Event Type  malfunction  

Event Description

"caller alleged imprecision with inratio meter.Results as follows:" 1.3 and 3.8.Therapeutic range: 2.0-3.0.Minutes between tests on difference fingers.

Manufacturer Narrative

It is indicated that product is not returning for eval.Therefore, investigation of the complaint to determine root cause cannot be completed.Retain strip testing results met both accuracy and precision criteria.A review of the mfr record for the lot did not uncover any non-conformance.Lot meets release spec.Root cause could not be determined from the info provided by the customer.Based on the info available, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subject to tracking and trending.

• Brand Name: INRATIO2
• 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: 3704908
• MDR Text Key: 18854213
• Report Number: 2027969-2014-00002
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/10/2013

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: 100139
• Device Lot Number: 312583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/02/2014
• 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: COUMADIN; DOXYCYCLINE