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

Model Number 100071

Device Problems Nonstandard Device (1420); Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Myocardial Infarction (1969); Thrombus (2101)

Event Date 06/15/2010

Event Type  malfunction  

Event Description

On 12/19/2014, a phone call was received from the patient's wife inquiring if her husband's death had anything to do with the information listed in the notification that she had received.In an attempt to obtain complete information, the distributor, alere home monitor, inc.(ahm), was contacted and the following is a chronological summary of available information.04/26/2010: monitor shipped.05/01/2010: inratio=1.3.05/03/2010: patient was having difficulty obtaining enough blood for sample and received "nes and lo" errors.There was no result obtained.05/04/2010: inratio=1.3.05/11/2010: inratio=1.3.(b)(6) 2010: inratio=1.4 (patient reported a critical value and notified their health care provider).(b)(6) 2010: patient was getting errors on first try but feels confident in the use of monitor.(b)(6) 2010: inratio=1.6.(b)(6) 2010: inratio=1.7.(b)(6) 2010: inratio=1.0 (date of event: start of result discrepancy).(b)(6) 2010: inratio=5.0.(b)(6) 2010: inratio=3.7.(b)(6) 2010: inratio=1.5.(b)(6) 2010: inratio=3.6.07/20/2010: inratio=3.1.07/26/2010: inratio=3.8.08/03/2010: wife reported that patient was hospitalized and not sure if he would be testing again.There was no information provided related to the hospitalization.08/09/2010: inratio=1.8 (this was the last result reported to ahm.) if medication was adjusted, after a result that was obtained outside the patient's therapeutic range of 2.0 - 3.0, that could explain the discrepancy in the inr result the following week.Though requested, additional information could not be provided regarding anticoagulation therapy changes in relationship to inratio inr results or hospitalizations.There was no laboratory confirmation results reported.08/17/2010: wife reported that patient will be taken off coumadin for a while and doesn't know if he will resume testing.12/2010: the patient was discharged from ahm due to the discontinuation of coumadin.04/03/2012: account closed, "patient is off coumadin." 04/2012: per wife monitor returned to ahm.04/16/2012: monitor returned to ahm per account; however, ahm warehouse log did not shows that monitor was received.12/2012: the patient's coumadin on hold in preparation for a stent procedure.This was reported to be the patient's second or third stent procedure.01/23/2013: the patient expired related to "heart attack caused by blood clots".The report filing is due to the discrepancy in the patient result starting 6/15/2010.The result discrepancy did not cause or contribute to the subsequent death which occurred nine (9) months after the monitor was reported to have been returned to ahm.Though requested, there was no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Corrections: brand name: removed the inratio2 pt monitoring system (monitor) and added the inratio pt/inr test strips (as the complaint device).Model #: removed the inratio2 pt monitoring system (monitor) and added the test strips model 100071.Serial#: removed the serial number which was related to the monitor.Removed the test strips as a concomitant medical product and add the inratio2 pt monitoring system.Removed the inratio2 pt monitoring system 510k# k072727 and added k092987 to reflect the pt/inr test strips investigation/conclusion: the customer's wife was inquiring if her husband's death had anything to do with the information listed in the notification letter she had received.The customer was not using the inratio monitor at the time of their death since the monitor had been returned approximately nine (9) months prior.Through the investigation, several inratio results were obtained from alere home monitoring, inc.; however, there was no lot number(s) provided.Since the product(s), associated with the complaint, were not returned and a lot number was not provided; further investigation into this issue was not possible.Further investigation will be pursued if the monitor is returned or if additional information becomes available.

• 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: 4413522
• MDR Text Key: 22061495
• Report Number: 2027969-2015-00022
• 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
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/19/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 01/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2015
• 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
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: INRATIO PT/INR EST STRIPS LOT UNKNOWN; INRATIO PT/INR TEST STRIPS LOT NUMBER: UNKNOWN
• Patient Age: 71 YR