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

Model Number 100071

Device Problems Low Test Results (2458); Human-Device Interface Problem (2949)

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

Event Date 02/24/2015

Event Type  malfunction  

Event Description

The caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.The following is a chronological order of events: (b)(6) /2015: inratio inr=1.6, strip# 334577.There was no increase in medication.The patient was taking coumadin 9mg.On (b)(6) 2015: inratio inr=1.4, strip# 349906.The patient's coumadin was increased from 9mg to 10mg.On (b)(6) 2015: the patient was hospitalized for a urinary tract infection (uti) and dehydration which was not related to the device.Patient was started on unspecified antibiotics.On (b)(6) 2015: laboratory inr=3.0 the variance between the inratio inrs and the laboratory inr can be explained by the increase in coumadin starting on (b)(6) 2015.On (b)(6) 2015: inratio=1.0, strip#349906.This is considered the date of the event since this was the start of the unexplained variance.On (b)(6) 2015: laboratory=2.4; inratio=2.5, strip# 349906.The testing was performed within 3 hours.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion: the customer reported discrepant low inratio inr results during testing.It is indicated that product is not returning for evaluation.Therefore, an investigation of the complaint to determine root cause cannot be completed.Since the product associated with the complaint was not returned, a review of in-house testing data was performed.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot did not uncover any non-conformances and the lot met release specification.A 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 and 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 (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: 4620543
• MDR Text Key: 5656456
• Report Number: 2027969-2015-00202
• 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,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• 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: 349906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2015
• 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); COUMADIN; IV ANTIBIOTICS FROM (B)(6) 2015; CEFADROXIL TAKEN FROM (B)(6) 2015; INRATIO PT/INR TEST STRIPS LOT# 334577