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

Model Number 100071

Device Problem 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 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio values.Patient's therapeutic range 2.5 - 3.5; (b)(6) 2015 inratio inr = 7.5; (b)(6) 2015 inratio inr = 1.9; (b)(6) 2015 inratio inr = 5.7; lab inr 5.1 time between tests three hours.Patient's warfarin held (b)(6) 2015 - (b)(6) 2015 and started 5mg every other day on (b)(6) 2015.Patient started wafarin dosage of 5 mg everyday on (b)(6) 2015.Warfarin taken for a mechanical heart valve; simvistatin 20 mg for cholesterol losartan potassium 50 mg for hypertension no reported adverse patient sequela.

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house testing on strip lot 372984a was found to be performing within expectations.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.Root cause cannot be determined from the information provided.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: 5332628
• MDR Text Key: 35064519
• Report Number: 2027969-2015-01032
• 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: 12/07/2015

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: 100071
• Device Lot Number: 372984A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• 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