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 Problems Bronchitis (1752); Pneumonia (2011)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

Patient self tester reported lot to lot variability when testing her inratio.Results as follows: ln 362393: (b)(6) 2015 1.6, (b)(6) 2015 4.5.Ln 367324: (b)(6) 2015 1.5, (b)(6) 2015 1.2.Patient's therapeutic range: 2-3.Patient was milking finger after finger stick; unable to obtain sufficient blood sample.Patient was hospitalized (b)(6) 2015 for pneumonia, bronchitis; was on antibiotics only during hospitalization.This mdr is for lot 367324; reference mdr 2027969-2015-00386 for lot 362393a4.

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 product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot #367324 did not uncover any non-conformances.Lot meets release specification.Although improper techniques were identified in the complaint, these could not be ruled out as a possible cause of the unexpected results.In addition, the customer has (b)(6).The customer's blood sample may have interfered with the coagulation test.This may have contributed to the unexpected results observed by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Since the meter was not returned, the impedance curve associated with the discrepant result could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has been identified as part of an internal investigation to contribute to a potential discrepant result.Internal investigation has determined that certain patient conditions ((e.G.Low hematocrit, elevated plasma proteins) can contribute to weak slope change impedance curves.It was noted that the patient was hospitalized (b)(6) 2015 to (b)(6) 2015 for pneumonia and bronchitis.Chronic inflammatory conditions and acute infections have been identified as conditions that may contribute to a discrepant inr result.

Event Description

Patient self tester reported lot to lot variability when testing her inratio.Results are as follows: ln 362393a: (b)(6) 2015 1.6, (b)(6) 2015 4.5.Ln 367324a: (b)(6) 2015 1.5, (b)(6) 2015 1.2.This mdr is for lot 367324a; reference mdr 2027969-2015-00386 for lot 362393a.Both lot numbers are being corrected since neither had the 'a' at the end.

• 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: 4815978
• MDR Text Key: 5898483
• Report Number: 2027969-2015-00387
• 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,consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2015

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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 367324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 06/03/2015
• 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: 2ND STRIP LOT #362393A