MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number	200431
Medical Device Problem Codes	Nonstandard Device (1420); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Coagulation Disorder (1779); Death (1802); Hemorrhage/Bleeding (1888)
Date of Event	02/12/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is pending.
Event or Problem Description
On (b)(6) 2016 a home health company, that had rendered care to a patient, notified (b)(4) of a variance between an inratio inr result and a laboratory inr result and subsequent patient death.Upon (b)(4) follow-up, the following information was received.Timeline of events: prior inratio or laboratory inr results were unable to be provided.On (b)(6) 2016, a venous draw was performed at the patient's home and sent to the laboratory for inr testing.The inr result was not provided to the patient that day; therefore, the patient took his normal dosage of coumadin 7.5mg.On (b)(6) 2016, the laboratory inr result was received and was 8.0.The patient was instructed to hold his dosage for the evening.It was not clear who had provided this instruction to the patient (physician, coumadin clinic, or someone form the lab).During the night, the patient experienced a couple of nosebleeds, but did not seek medical attention.On (b)(6) 2016, the home health nurse visited the patient to check his inr and the patient commented on his nosebleeds that occurred the previous night.The patient fell before the nurse was able to test the patient's inr.Emergency medical services (ems) was called.While ems was en route, the nurse attempted to test the patient with the inratio monitor and received an error message, but could not recall the specific message.Since the finger stick site had not coagulated, the nurse used the same finger stick site to perform a second test which resulted in an inr of 1.7.The nurse reported that a large drop of blood would not form since the blood flowed continuously resulting in multiple drops of blood being applied to the test strip.The patient's therapeutic range was 2.0 - 3.0.The nurse stated that she did not believe the inr test result was accurate based on the patient's clinical picture.The patient's coumadin clinic was notified and it was recommended that the patient go to the hospital.The nurse reported that when ems arrived they differed with the recommendation to take the patient to the hospital and said that the patient should be monitored at home based on the inratio inr value only.The coumadin clinic was notified and the patient was instructed to go to the clinic.The patient's wife drove him to the clinic where the physician met the patient in the parking lot.An unspecified point of care (poc) monitor was used for the patient's inr testing which resulted in an inr of >8.There was approximately one hour between testing on the inratio and clinic's poc monitor.Based on the poc inr result, the physician administered vitamin k 5mg and the patient was instructed to go to a nearby hospital.At the hospital, the laboratory inr was 6.5.A computerized tomography (ct) scan was performed which indicated a small bleed; the location of the bleed was not known.The patient was then transferred to (b)(6).Within six hours of being admitted to the icu, the patient developed a major brain bleed and subsequently passed way on (b)(6) 2016.The exact cause of death is not known to the patient's wife or to the home health nurse.There was no additional information provided.
Additional Manufacturer Narrative
Investigation/conclusion: alere (b)(4) received the returned inratio2 monitor on 02/25/2016.The monitor continued to meet all functional testing specifications.Testing using samples from therapeutic donors met all accuracy criteria and testing using retained strips from the same test strip lot used by the customer did not replicate the customer's issue.A review of the manufacturing records found that there were no non-conformances in the monitor lot.The relevant test strip lot testing history showed accuracy of 97.4%.An examination of the impedance curve associated with the 1.7 inr result recorded for the customer on (b)(6) 2016 showed a perturbed waveform.The technique issues described in the original report may have caused the perturbed curve, but this cannot be definitively established based on the information reported.

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• Common Device Name: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 5500603
• Report Number: 2027969-2016-00139
• Device Sequence Number: 430518
• Product Code: GJS
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2016

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?: Yes
• Operator of Device: Nurse
• Device Model Number: 200431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2016
• Supplement Report FDA Received Date: 04/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NIACIN 500MG DAILY (ORAL)
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 82 YR