MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO 2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

Device Problems Nonstandard Device (1420); Low Test Results (2458)

Patient Problems Bruise/Contusion (1754); Death (1802); Dyspnea (1816); Hemorrhage/Bleeding (1888); Thrombosis (2100); Constipation (3274)

Event Date 12/08/2014

Event Type  Death  

Event Description

On (b)(6)2014, the distributor, alere home monitoring, inc (ahm) reported the following to alere san diego, inc.: date inratio lab (b)(6)2014 3.0 --- (b)(6) 2014 --- 7.9 therapeutic range: 2.0-3.0 the patient self tester (pst) was admitted into hospital on (b)(6) 2014 due to difficulty breathing and extreme constipation.Pst also had unusual bruising and bleeding at time of admission.Lab inr at time of admission was 7.9.While in the hospital, blood clots were found in the patient's legs and lungs.No additional information is available.Patient died on (b)(6)2014 due to unknown causes.Though requested, there was no additional information provided.

Manufacturer Narrative

The products associated with the complaint were returned for investigation.The complaint of a discrepant low result was not replicated when the returned monitor and strips were tested using in-house donors.A review of the manufacturing records for the lot did not uncover any non-conformances.This lot met release specifications.The impedance curve analysis associated with this case exhibited a weak slope change.Our capa investigation ((b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.The capa investigation has also determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to weak slope change impedance curves.The patient had kidney disease and rheumatoid arthritis at the time of the alleged discrepant result.(b)(4) has identified kidney disease and chronic inflammation as conditions that may contribute to a discrepant inr result.A notification letter has been sent to customers to inform them of these patient conditions.A possible root cause is the patient conditions of kidney disease and rheumatoid arthritis which 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 into these issues will be pursued under (b)(4).

• Brand Name: INRATIO 2 PT MONITORING SYSTEM
• 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 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4433686
• MDR Text Key: 5384320
• Report Number: 2027969-2015-00046
• 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: Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/22/2014

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: 12/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED HIGH BLOOD PRESSURE MEDICATION; WATER PILL; COUMADIN; STRIP PART #(B)(4), LOT 347476
• Patient Outcome(s): Death; Hospitalization