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); Incorrect Or Inadequate Test Results (2456)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 12/25/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio values.Patient's therapeutic range: 2.0 - 2.9.(b)(6) 2015 inratio inr = 1.2; lab inr = 3.4 time between tests five minutes.(b)(6) 2015 inratio inr = 1.2; md poc inr = 1.7; lab inr = 1.7 patient tested first on md poc, followed by inratio and finally lab draw.No reported adverse patient sequela.

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review in-house testing was performed.In-house strip testing on strip lot 360632 meets criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any relevant non-conformances.Lot meets release specification.Root cause could not be determined from the information provided 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 road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5384640
• MDR Text Key: 36772806
• Report Number: 2027969-2016-00043
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• 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: 360632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: No
• 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