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

Model Number 100071

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017); Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Date 03/20/2015

Event Type  Injury  

Event Description

The caller alleged discrepant low inratio inr results in comparison to the laboratory inr result.Results are as follows: date inratio inr laboratory inr (b)(6) 2015 1.4 4.9 therapeutic range: 2.5 - 3.5 the time between testing was three (3) to four (4) hours.The customer added multiple drops of blood to the sample well on the inratio testing strip.This is considered to be an improper technique.Additionally, the caller reported a history of lupus.On (b)(6) 2015, the customer took only 2mg of warfarin instead of 5mg based on the laboratory inr result.On (b)(6) 2015, the inratio inr was 1.2.There was no reported reference comparison.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.The retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed.The lot met specifications and no non-conformances were documented.Improper technique was identified in the complaint.This cannot be ruled out as a possible root cause for the unexpected results.The customer has lupus.Testing with an aps-insensitive laboratory method is recommended for these patients.The customer's current health status cannot be ruled out as a possible root cause for the unexpected results.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: 4629068
• MDR Text Key: 5572319
• Report Number: 2027969-2015-00213
• 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: Patient
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 361978A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 03/24/2015
• 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 5MG AND 7.5MG ALTERNATING; INRATIO MONITOR SN (B)(4); TOOK LOVENOX THE WEEK PRIOR; UNSPECIFIED OTHER MEDICATIONS
• Patient Outcome(s): Required Intervention