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

Model Number 100071

Device Problem High Test Results (2457)

Patient Problem Urinary Tract Infection (2120)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

Caller alleged discrepant high inratio inr results.Results are as follows: date inratio inr (b)(6) 2014 1.9 and 4.1 the time between testing was one (1) hour.Reportedly, patient being treated for urinary tract infection (uti).Therapeutic range 2.0 - 3.0 for the patient.There was no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion: 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 manufacturer record for the lot did not uncover any relevant non-conformance.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.Correction as follows: delete: the time between testing was one (1) hour; add: the time between testing was unknown for this patient.

• 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 Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4333884
• MDR Text Key: 5247057
• Report Number: 2027969-2014-01089
• 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,Followup
• Report Date: 12/02/2014

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: 355823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• 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; SPECIFIED ANTIBIOTICS