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); Paresis (1998); Thrombosis (2100); Dysphasia (2195); Ambulation Difficulties (2544); Lethargy (2560)

Event Date 04/19/2014

Event Type  Injury  

Event Description

A maude event report (mw5040230) was received on (b)(6) 2015.The wife of the end user/patient was contacted to obtain details of the event as follows: on (b)(6) 2014, the patient tested on the inratio device and received an inr of 2.5.The patient's therapeutic range was 2.0 - 3.0.Ten (10) days later, on (b)(6) 2014, the patient experienced somnolence, global aphasia and right hemiplegia.Upon arrival to the hospital, the laboratory inr was 2.1 and the patient was reported to have experienced a massive stroke due to a clot in his left middle cerebral artery.A clot was removed by the neuroradiologist within ninety (90) minutes of symptom onset.Following the clot removal, the patient spent one (1) week in acute care and two (2) weeks in rehabilitation.The patient has since been released home.The patient has recovered his speech, however, he continues to have receptive aphasia and severe gait deviations and instability.The wife reported that this has improved over time but is still present.Following the hospitalization, the patient has changed to xalerto and is no longer using the inratio device.The wife reported that there was no problem with the device, but just wanted to report the episode since she had received the alere inratio pt/inr monitor system urgent medical device correction notification, dated (b)(6) 2014.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of the event.The last inratio inr was ten (10) days prior to the event.The coagulation status can significantly change during this period of time.Based on the inability to rule out the possibility that the device may have caused or contributed to the clotting, this event is conservatively reported as a serious injury based on the blood clot being potentially related to the patient's coagulation status; however, a device deficiency cannot be substantiated.There was no additional information provided.

Manufacturer Narrative

(b)(4).Investigation/conclusion: the customer's wife was unable to provide a lot number and no products were returned 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 a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of the event.The last inratio inr was ten (10) days prior to the event.The coagulation status can significantly change during this period of time.Based on the inability to rule out the possibility that the device may have caused or contributed to the clotting, this event is conservatively reported as a serious injury based on the blood clot being potentially related to the patient's coagulation status; however, a device deficiency cannot be substantiated.

• 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
• MDR Report Key: 4827675
• MDR Text Key: 20121752
• Report Number: 2027969-2015-00396
• 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
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/18/2015

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: 05/18/2015
• Initial Date FDA Received: 06/09/2015
• 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: COUMADIN; LEVOTHYROXINE; ASPIRIN 81MG; INRATIO MONITOR SN (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention