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

Model Number 100071

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

A variance was reported between inratio inr results.The results were as follows: on (b)(6) 2016: inratio=4.3, inratio=1.6 , 5 min apart.On (b)(6) 2016: inratio=1.7 , 20 mins after 1.6 result.Reported therapeutic range: 2-3.It was reported that the finger was being milked after the finger stick and multiple finger sticks were performed on the same finger.For the inratio=1.7, a new finger was used for testing.

Manufacturer Narrative

The product was not returned for evaluation.Therefore, a review of the entire testing history for the reported lot was performed.In-house testing on strip lot 370105ar meets release criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any relevant non-conformances; the lot met release specifications.Technique issues were identified in the complaint which may have contributed to the precision issue experienced by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5704855
• MDR Text Key: 48030003
• Report Number: 2027969-2016-00425
• 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,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• 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: 370105AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• 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