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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

On (b)(6) 2015, a phone call was received from the patient's son after he received the alere inratio pt/inr monitor system urgent medical device correction notification, dated (b)(6) 2014.The son stated that the notification was received the day after his (b)(6) father expired in (b)(6) 2014 (date of death: (b)(6) 2014 per (b)(6) obituary).The cause of death was reported to be cardiac arrest; however no autopsy was performed.The son wondered if the monitor caused his father's death.He reported that the readings were "going from one extreme to the next." the results tended to shift dramatically from week to week for instance approximately 4.1 then 1.0 the next week.The warfarin was adjusted based on the inratio result on a week-to-week basis.The patient had multiple medical conditions, was bed-ridden and was scheduled for hospice when he expired.The distributor, (b)(4), was contacted in an attempt to obtain additional information.The following is a chronological history of available information and inratio inr results.(b)(6) 2014: inratio inr=4.2, (b)(6) 2014: inratio inr=1.4, (b)(6) 2014: inratio inr=2.1, (b)(6) 2014: inratio inr=2.1.The weekly warfarin dosage adjustments, that were reported, could explain the variance in the inr result from 4.2 on (b)(6) 2014 to 1.4 on (b)(6) 2014.There is no information available to suggest that the device caused or contributed to the reported event.The patient's son could not provide information regarding details of the event.This event is conservatively reported as a malfunction due to the variance in the patient's results starting (b)(6) 2014.We have no evidence that the variance in the inr results (which may have been due to the weekly dosage changes) caused or contributed to the subsequent death which occurred approximately two (2) weeks later.Though requested, there was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the patient's son did not provide a lot number or return the device for investigation.Since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.There is no information available to suggest that the device caused or contributed to the reported event.The patient's son could not provide information regarding details of the event.This event is conservatively reported as a malfunction due to the variance in the patient's results starting (b)(6) 2014.We have no evidence that the variance in the inr results (which may have been due to the weekly dosage changes) caused or contributed to the subsequent death which occurred approximately two (2) weeks later.Though requested, there was no additional information provided.

• 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 (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: 4745547
• MDR Text Key: 5821522
• Report Number: 2027969-2015-00304
• 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: Other,Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/06/2015

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: 04/06/2015
• Initial Date FDA Received: 05/04/2015
• 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
• Patient Sequence Number: 1
• Treatment: UNKNOWN OTHER MEDICATIONS; INRATIO MONITOR SN (B)(4); WARFARIN 1MG M/T/W/F/SA AND 0.5MG TH/SU
• Patient Age: 76 YR