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

Model Number 200432

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The caller alleged a variance between the inratio inr results and the laboratory inr result.Results are as follows: date: inratio2 inr: laboratory inr: (b)(6) 2015, 1.8, n/a; (b)(6) 2015, 3.1, 7.05; therapeutic range: 2.0 - 3.0.On (b)(6) 2015, there was no jantoven dosage change since the patient and the physician felt that the result was inaccurate.On (b)(6) 2015, the testing was performed consecutively.The patient's jantoven dose was held from (b)(6) 2015.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the monitor and remaining test strips associated with the complaint was returned for investigation.The customer's complaint was not confirmed during in-house testing.Returned and retained strips tested on the returned monitor met accuracy criteria.The testing history for lot 372984a was reviewed and the lot met release specification.The manufacturing records for the lot were reviewed and the lot met release specifications.The product performed as expected.The returned monitor passed functional and thermistor testing requirements during in-house investigation.The impedance curve associated with the customer's inratio inr result of 1.8 was analyzed statistically and determined to be normal in shape.The impedance curve associated with the customer's inratio inr result of 3.1 was also analyzed statistically and was determined to possess a weak slope change.Capa investigation (capa (b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.It was also determined that certain patient conditions can contribute to weak slope change impedance curves.The customer had rheumatoid arthritis at the time of the alleged discrepant result.Capa (b)(4) has identified conditions associated with chronic inflammation as those that may contribute to discrepant inr results.A notification letter has been sent to customers to inform them of these patient conditions.A possible root cause is that the patient condition of rheumatoid arthritis may have contributed to an impedance curve that exhibited a weak-slope change.The inratio monitor software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.Further investigation performed under capa (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: 5104554
• MDR Text Key: 26788629
• Report Number: 2027969-2015-00705
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• 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: 09/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• 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: JANTOVEN
• Patient Outcome(s): Required Intervention