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

Model Number 100071

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 05/27/2015

Event Type  Injury  

Event Description

The customer reported a correlation issue.On (b)(6) 2015, the inratio inr results were 5.0, 2.5, 3.8 and 5.2.All testing performed within10-15 minutes.Reportedly, improper technique was performed by multiple finger sticks being performed on the same finger.The customer does not remember which results the same finger was used for.After receiving a variety of results on (b)(6) 2015, the physician had the patient hold the warfarin that night since most of the results were higher than the therapeutic range of 2.0-3.0.The following day ((b)(6) 2015) the inratio was 2.3 and the lab was 2.9, both result are within the therapeutic range.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the customer did not provide a lot number or return any products for investigation.Since the products associated with the complaint were not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.

• 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: 4878911
• MDR Text Key: 21088013
• Report Number: 2027969-2015-00453
• 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
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/30/2015
• 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: INRATIO MONITOR SN (B)(4); WARFARIN 12.5MG ON SU/TU/TH AND 10MG ON M/W/F/SA
• Patient Outcome(s): Required Intervention