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

Model Number 100071

Device Problem Nonstandard Device (1420)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Type  Death  

Manufacturer Narrative

Exact date of death is unknown - sometime in (b)(6) 2015.Investigation conclusion: investigation pending.

Event Description

The wife of the patient self tester (pst), initially contacted alere technical services (b)(6) requesting to be removed from the inratio recall notification.The caller informed technical service representative that her husband had suffered from a stroke in (b)(6) 2015, which led to his passing at their home.Caller stated the patient was testing on the inratio monitor leading up to his stroke.The caller wanted to know if the inratio may have contributed to the patient's stroke and ultimately his death.The caller stated there were no issues with results leading up to the patient's stroke.Additionally, she stated she had disposed of the inratio products and inr logs since (b)(6) 2015 so she could not provide any results or product information such as lot #, number of strips or the meter serial number.Pst had been on antibiotics around the time of (b)(6) 2015, for an unspecified condition.Caller was unable to confirm if the patient had been enrolled in a monitoring service or if they received the 2014 medical device correction letter.No additional information or details were provided.There is no information available to suggest a malfunction or that the device caused or contributed to the reported death.The reporter could not provide information regarding details of the event.This event is conservatively reported due to alleged deficiency that cannot be substantiated without access to additional data or results.

Manufacturer Narrative

Correction: remove adverse event.Remove death - death not related to inratio product.Updated information:.During the investigation, on january 4, 2017, alere confirmed with alere home monitoring (ahm) that the patient self-tester (pst) did not use an alere inratio monitor near the time of the pst's death, but rather the pst was using the roche coaguchek xs meter.Thus, the death of the pst was not associated with the alere inratio monitor.The pst was issued a coaguchek xs meter on (b)(6) 2015 (5 months prior to the pst's death) and was not issued an inratio monitor.The pst trained on the coaguchek xs system on 6/9/2015, and ordered coaguchek test strips on 6/3/2015 and 10/8/2015.Based on this confirmation, both alere and ahm reported the complaint to roche and were provided with roche case (b)(4).

• 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: 6211518
• MDR Text Key: 63468417
• Report Number: 2027969-2016-00707
• 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,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

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?: No
• 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: 12/07/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: No
• 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-2354-2016 Z-2362-2016
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR SERIAL # UNKNOWN; UNSPECIFIED ANTIBIOTICS
• Patient Outcome(s): Death