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

Model Number 100071

Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017); Low Test Results (2458)

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

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.Results are as follows: date, inratio inr, laboratory inr: (b)(6) 2015, 2.6, 6.5.The time between testing was 30-45 minutes.Reportedly, the strips are past their expiration date and "milking" finger after finger stick therapeutic range 1.9 - 3.1 for the patient.There was no reported adverse event.There was 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.An improper technique was identified in the complaint.This could not be ruled out as a cause of the unexpected results.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.

• 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: 4553432
• MDR Text Key: 17333255
• Report Number: 2027969-2015-00148
• 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
• Report Date: 02/25/2015

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: 308051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 02/27/2015
• 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: UNSPECIFIED THYROID MEDICATION; INRATIO MONITOR, SN: (B)(4)