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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Bruise/Contusion (1754)

Event Date 03/07/2015

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Patient self tester's mother (b)(6) called in with an alleged precision issue while testing her son's inr with inratio.The patient self tester's mother does the testing and the nurse adjusts the coumadin dose depending on the inr result.Results were as follows: (b)(6): inratio=1.5, coumadin increased from 8 mg/day to alternating 8 mg/day with 9 mg/day.(b)(6): inratio=2.3, thus remained at the alternating dosing schedule.(b)(6): inratio=3.2, bruising, which stated "did not appear to be spontaneous, he may have fallen"; so dropped coumadin back down to 8 mg/day.(b)(6): inratio=2.6.(b)(6): inratio=1.2, 14 hours later increased the coumadin dose to 9mg.(b)(6): called tech service dept; while on the phone she retested him and got an inr=3.1.No bruising observed.Intends to resume 8 mg and will consult with physician.Patient self tester's therapeutic range is: 2-3.

• 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: 4628683
• MDR Text Key: 19071240
• Report Number: 2027969-2015-00212
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 03/07/2015

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: Patient Family Member or Friend
• Device Model Number: 100071
• Device Lot Number: 355822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2015
• 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: INRATIO MONITOR SN: (B)(4); COUMADIN