MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR TEST STRIP; PROTHROMBIN TIME TEST

Model Number 99007G1

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2014

Event Type  malfunction  

Event Description

"caller alleged imprecision with inratio meter.Results as follows:" first result 4.4 inr, second 1.5 inr (from same finger prick).Repeat done on different finger prick result 4.4 inr.Patient self tester's therapeutic range: 2-3.Caller reported that he had a discrepant result with the inratio test results; he was using expired test strips ordered from (b)(6).He was told when he called in previously not to use the expired strips and to discard them.He continued to use them and got a result of 4.4 inr; then tested with alere inratio strip lot 299623 and got 1.5 inr.Customer called back a third result of 4.4 inr which matched the initial result (again informed him not to use the expired strips) and advised him to see his physician.Patient called back on (b)(6) 2014 with his latest inratio result = 2.9.The customer stated that he looked into the side effects of the anti viral drug called famciclovir 500 mg tablets, and it would appear that this was the cause of the high inr reading not faulty test strips.Customer sent email on (b)(6) 2014; he tested again with a result of 2.0.

Manufacturer Narrative

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 data was performed.Retain strip testing results met both accuracy and repeatability criteria.The products performed as expected an no product deficiencies were observed.Although the root cause analysis did not include return testing, improper techniques were identified in the complaint.These could not be ruled out as a cause of the unexpected results.The customer utilized expired strips during testing.The inratio testing strips lot number 299623 with strip code uu69c expired january 2014.Use of the product beyond the expiration date can result in errors or inaccurate results.The customer's use of expired products may have contributed to the unexpected results.The manufacturing records for the lot were reviewed.The lot met specifications and no non-conformances were documented.No further investigation will be pursued at this time.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: INRATIO2 PT/INR TEST STRIP
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4015963
• MDR Text Key: 4878105
• Report Number: 2027969-2014-00743
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 99007G1
• Device Lot Number: 299623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2014
• 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: MEDICATION FOR SHINGLES; WARFARIN; FAMCICLOVIR 500 MG TABLETS