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

Model Number 100071

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); Hematoma (1884)

Event Date 02/23/2016

Event Type  Death  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.As the patient's wife was unable to provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.Based on the information available, there is no indication of a product deficiency and no corrective action is required.A capa, (b)(4), was initiated to address the late documentation of this event.

Event Description

The patient's wife initially called to inquire how to return the patient's inratio system.The patient began using the inratio system in (b)(6) 2013.On (b)(6) 2016, the patient was admitted to the hospital due to a headache and confusion that had been occurring for approximately 3-4 days.Ct head scans conducted on the patient revealed a large right hemorrhagic lesion (intracerebral hematoma) in the brain with surrounding vasogenic edema and shift.The hematoma was determined to be related to warfarin use.On admission, the patient's coagulation was reversed acutely in the emergency department.During the hospital visit, the patient was in the intensive care unit and suffered from confusion, restlessness, and difficulty recalling simple information.Tests were conducted to monitor the progress of the patient's physical and mental state, but the patient's condition continued to deteriorate due to the hematoma.On (b)(6) 2016, the patient was discharged to hospice for symptom management of dyspnea, pain, and agitation.The patient passed away on (b)(6) 2016.The wife stated that the patient died due to a brain bleed.The patient's death certificate was obtained; however, it does not contain a cause of death.The patient's cause of death could not be confirmed.Although a device deficiency cannot be substantiated, this event is being conservatively filed.

Manufacturer Narrative

(describe event or problem) updated to include information regarding medical records received 09/15/2017.

Event Description

The patient's wife initially called to inquire how to return the patient's inratio system.The patient began using the inratio system in (b)(6) 2013.On (b)(6) 2016, the patient was admitted to the hospital due to a headache and confusion that had been occurring for approximately 3-4 days.Ct head scans conducted on the patient revealed a large right hemorrhagic lesion (intracerebral hematoma) in the brain with surrounding vasogenic edema and shift.The hematoma was determined to be related to warfarin use.On admission, the patient's coagulation was reversed acutely in the emergency department.During the hospital visit, the patient was in the intensive care unit and suffered from confusion, restlessness, and difficulty recalling simple information.Tests were conducted to monitor the progress of the patient's physical and mental state, but the patient's condition continued to deteriorate due to the hematoma.On (b)(6) 2016, the patient was discharged to hospice for symptom management of dyspnea, pain, and agitation.The patient passed away on (b)(6) 2016.The wife stated that the patient died due to a brain bleed.The patient's death certificate was obtained; however, it does not contain a cause of death.The patient's cause of death could not be confirmed.Although a device deficiency cannot be substantiated, this event is being conservatively filed.On 09/15/2017, extensive medical records were received regarding this event.The medical records describe the same event and no new complaint is alleged.There is no reported information that would alter the initial mdr reporting decision or mdr filed.

Manufacturer Narrative

On (b)(6) 2017, an executive summary and review of the patient's medical was received.The following sections have been updated to reflect the additional information: (describe event or problem) and (other relevant history) updated to include additional information.

Event Description

The patient's wife initially called to inquire how to return the patient's inratio system.The patient began using the inratio system in (b)(6) 2013.On (b)(6) 2016, the patient was admitted to the hospital complaining of four days of confusion, slow mentation, nausea with no vomiting, diarrhea, and headaches.He had also experienced difficulty driving and parking his vehicle.Laboratory studies on admission included a platelet count of 67 and protime of 22.6 and inr of 2.05.Ct of the head revealed a large hemorrhagic lesion in the right temporoparietal area measuring approximately 4.8 x 4.7 cm with vasogenic edema.There was partial effacement of the occipital horn of the right lateral ventricle and a 6 mm leftward shift.Neurosurgery and neurology consultations were obtained.Was given vitamin k, decadron iv, dilaudid for pain, zofran for nausea, and keppra for seizure prophylaxis.He was admitted to the icu.The patient initially was able to move all four extremities, was oriented to time/place/person, had good recent and remote memory, and functional language abilities.There were some left visual field voids.On (b)(6) 2016, the day after admission, there was minimal left facial paresis but moderate to severe left side neglect with little movement to command, although he was able to spontaneously move his left arm and leg.Platelets were 48, inr was 1.32, and aptt was 41.Repeat ct was stable.The patient and his wife were planning to return to kentucky for continued care.Neurosurgery estimated it would be safe for them to travel by the end of the week.Neurological status somewhat declined on (b)(6) 2016, although he remained alert and oriented.There was a left facial droop with impaired left heel to shin and left fine finger movements.Platelets were 54, protime was 15.6, inr was 1.25, and aptt was 38.Ct of the head remained unchanged.The patient was generally more sleepy and somewhat difficult to arouse.Level of mentation and physical responses continued to decline over the ensuing days.Medication was given for agitation and confusion.By (b)(6) 2017 barber is described as being minimally verbal.A sitter was required.Serial ct scans, eventually as often as every 12 hours, showed that there was no extension of the bleed.Consultations were held with the patient's wife, his son, and with his son's wife, who is an aprn."do not resuscitate" requests were processed.The patient was transferred to inpatient hope hospice care on (b)(6) 2017.Comfort care was provided.The patient passed away on (b)(6).The wife stated that the patient died due to a brain bleed.The patient's death certificate was obtained; however, it does not contain a cause of death.The patient's cause of death could not be confirmed.Although a device deficiency cannot be substantiated, this event is being conservatively filed.

• 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: 6545840
• MDR Text Key: 74447483
• Report Number: 2027969-2017-00083
• 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,Followup,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• 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: INRATIO2 MONITOR, PN 200432, SERIAL# (B)(4)
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR