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

Model Number 100071

Device Problems Device Issue (2379); Incorrect Or Inadequate Test Results (2456)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Caller alleging discrepant inratio values.Patient's therapeutic range: 2.5 - 3.5.(b)(6) 2015 inratio = 4.7; repeat inratio = 6.9; 2nd repeat inratio = 7.5.Time between inratio tests 15 minutes between each test.(b)(6) 2015 lab = 3.1.Patient held warfarin medication on (b)(6) 2015.Unknown if physician ordered.Although requested, no additional information available.

Manufacturer Narrative

Investigation conclusion update: the products associated with the complaint were returned for investigation.The customer's complaint of discrepant high results was not confirmed during in-house testing.Returned and retain strips tested on the returned meter met both accuracy and repeatability criteria.The returned meter met functional and thermistor testing requirements during investigation.Although relevant ncs were noted in batch record, it did not affect the final release specifications.There is no indication of a deficiency with the strips and additional corrective actions were not required.The impedance curve analysis associated with this case found two impedance curves which exhibited a weak slope change.Capa investigation (capa-(b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.The capa investigation has also determined that certain patient conditions can contribute to weak slope change impedance curves.The customer did not report to have a medical condition that would interfere with the test.Although two technique issues were also identified in the complaint, root cause cannot be determined from the information provided.An impedance curve with weak-slope change has been identified in capa-(b)(4) to contribute to a potential discrepant result.Further investigation is being performed under capa-(b)(4) for this issue.

• 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: 4949701
• MDR Text Key: 23132307
• Report Number: 2027969-2015-00544
• 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
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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: 365984A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• 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