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

Model Number 100071

Device Problems Shelf Life Exceeded (1567); Incorrect Or Inadequate Test Results (2456)

Patient Problems Bronchitis (1752); Congestive Heart Failure (1783)

Event Date 03/03/2015

Event Type  Injury  

Event Description

Caller alleging discrepant inratio values.(b)(6) 2015; inratio 2.9; lab 5.9; <3 hours between tests.Patient's therapeutic range 2.0 - 3.5.Patient hospitalized on (b)(6) 2015 for bronchitis and chf.Warfarin held on (b)(6) 2015 for three days based on the 5.9 lab result received on (b)(6) 2015; warfarin resumed on (b)(6) 2015.(b)(6) 2015; inratio 2.5; lab 1.8; <3 hours between tests.Patient was using expired strips.Expiration date for strips was april 2014.No additional information provided.

Manufacturer Narrative

Investigation conclusion: it is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed while the strips were still within expiration.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed while the product was within expiration.The manufacturing records for the lot were reviewed.The lot met specifications and no non-conformances were documented.Customer is using a strip lot that expired on april 2014.Using expired product may be a root cause for the unexpected results 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.

Manufacturer Narrative

Investigation/conclusion update: the original investigation conclusion stated that a review of in-house testing was performed while the strips were within expiration.This was not correct.The strips were tested a month after expiration and performed as expected.

• 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: 4646647
• MDR Text Key: 5601561
• Report Number: 2027969-2015-00236
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 308051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2015
• 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: WARFARIN; AMOXICILLIN; INRATIO MONITOR SERIAL # (B)(4); LASIX
• Patient Outcome(s): Required Intervention