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

Model Number 100071

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 04/29/2015

Event Type  malfunction  

Event Description

The caller alleged a variance between inratio inr results.The results were as follows: around (b)(6) 2015 (patient self tester was not sure of date), he had an inratio=4.5 and 4.7 and did not question these results.(b)(6): inratio result was 1.7 and on (b)(6) inratio was 1.4.Patient self tester was concerned that results on (b)(6) were so low since no changes were made in his diet or medications.After result of inratio=1.7 on (b)(6), the patient self tester stated that his doctor told him not to take his warfarin over the weekend.Then on the evening of (b)(6) he was to take 2mg, (b)(6) evening 1.5mg, then tonight (b)(6) he was to take 4mg.Patient called to update that he took his monitor to the doctor's office for testing today.He used the new lot of strips (364994), got a inratio of 3.2, which he did not question.

Manufacturer Narrative

The customer did not provide any reference values for comparison.The accuracy of the customer's inratio results cannot be determined without this information.It is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.Retain strip testing results met both accuracy and strip 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 relevant non-conformances.The lot meets release specification.Root cause is unable to 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 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: 4806985
• MDR Text Key: 21465438
• Report Number: 2027969-2015-00379
• 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: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• 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: 355822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: WARFARIN; EFFIENT; INRATIO MONITOR SN: (B)(4); CRESTOR; VITAMIN B12 SHOT ONCE A MONTH