MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

Device Problem Low Test Results (2458)

Patient Problem Dizziness (2194)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The caller alleged a variance between the inratio inr result and the laboratory inr result.Historical inr results: (b)(6) 2015: inratio=2.8, (b)(6) 2015: inratio=2.0, (b)(6) 2015: inratio=1.7.Therapeutic range: 2.0 - 3.0.On (b)(6) 2015, the patient tested on the inratio and reported an inr of 1.7.On (b)(6) 2015, the patient presented to the emergency room with dizziness.The laboratory inr was 13.0.The patient was hospitalized, treated with vitamin k and was placed on a coumadin hold during the duration of the hospital stay.On (b)(6) 2015, the patient discharged from the hospital and his coumadin was decreased from his normal dose of 2 mg a day to 1 mg a day.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the monitor and testing strips associated with the complaint were returned for investigation.Functional and thermistor testing were performed on the returned monitor with passing results.The reported inratio inr results were present in the returned monitor memory; however, the results were not on the dates as reported by the customer.The monitor retains up to the last 4 impedance curves in the memory, since the curve associated with the customer's reported inratio inr result of 2.8 was not present in the last 4 curves, it was unable to be statistically analyzed.The impedance curves for the customer's results of 1.7, 1.7 and 2.0 were statistically analyzed and found to exhibit a weak-slope change.Internal investigation (b)(4) has determined that impedance curves with a weak slope change can cause discrepant results.The capa investigation has also determined that certain patient conditions can contribute to weak slope change impedance curves.No patient conditions were provided by the customer to determine if these led to the weak slope change observed.This issue is related to the algorithm software on the monitor and was addressed in (b)(4).Due to this root cause being identified as the cause of the customer discrepant result, donor testing of the monitor was not necessary.A review of in-house testing history for the lot 364994a was performed and the results met criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed and the lot met release specifications.Further investigation performed under (b)(4).

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): 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: 5150118
• MDR Text Key: 28242776
• Report Number: 2027969-2015-00846
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2016; 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: COUMADIN 2 MG DAILY
• Patient Outcome(s): Hospitalization; Required Intervention