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 Unspecified Infection (1930)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

Caller alleging discrepant inratio values.(b)(6) 2015 inratio 6.5 lab 7.2, (b)(6) 2015 inratio 3.3 lab 4.1, (b)(6) 2015 inratio 2.2 lab 1.8, (b)(6) 2015 inratio 2.2 lab 1.6.Thirty minutes between tests on all days.Patient's therapeutic range 2-3.Per doctor's request, patient discontinued coumadin on 04/13/2015 to prep for surgery.Doctors found patient had severe toe infection and was given 1500 mg of unspecified antibiotics for several days which elevated his inr.The doctor wanted the inr to be down to a 1.3 for surgery.The inr remained above the recommended level, therefore, the coumadin was resumed on (b)(6) 2015 and surgery will be performed at a later date.Though requested, no additional information available.No reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

Investigation conclusion.Investigation pending.

Manufacturer Narrative

Investigation/conclusion update: 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.

Manufacturer Narrative

Investigation conclusion: the meter associated with the complaint was returned for investigation.The customer's complaint of correlation issues were not confirmed during in-house testing.Retain strip testing on the returned meter met both accuracy and strip repeatability criteria.The product performed as expected and no product deficiencies were observed.The returned meter met functional and thermistor testing requirements during investigation.Impedance curve analysis could not be performed on the customer's result because only the last impedance curve can be retrieved from an inratio 1 meter.The customer's result was not the last impedance curve within the returned inratio 1 meter.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.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 road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4766766
• MDR Text Key: 5949589
• Report Number: 2027969-2015-00332
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2015

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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 361979A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/29/2015; 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNSPECIFIED ANTIBIOTICS; COUMADIN; INRATIO MONITOR SERIAL # (B)(4)