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

Model Number 200432

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Fall (1848); Pain (1994); Toxicity (2333)

Event Date 04/26/2014

Event Type  Death  

Event Description

On (b)(6) 2015, a call was received from the patient's daughter regarding the medical device correction letter (december 2014 recall).The daughter reported that the patient had a variance between the inratio inr result and the laboratory inr result and subsequently passed away of massive internal bleeding.Timeline of events: enrolled in (b)(6) in 2012.Historical results from (b)(6), around the time of the reported event: (b)(6).On (b)(6) 2014, the patient tested on the inratio monitor and received a 3.1; therefore she opted not to take her coumadin dose due to the result being elevated.The daughter reported that the patient had been within her therapeutic range of 2.0 - 3.0 with prior tests and no unusual bruising or bleeding.Shortly before midnight on (b)(6) 2014, the patient doubled over in pain and fell.The patient was taken by ambulance to the (b)(6) emergency room where the laboratory inr was 11.8 (daughter not sure of exact result but states that she believes it was 11.8).Asd has requested medical records from (b)(6).The daughter was also told that her mother was extremely anemic; however, there was no indication whether this was prior to the bleeding event.The patient was transfused with 4 units of prbc's and 4 units of ffp.She was also administered vitamin k 10mg subcutaneously and a dopamine infusion for low blood pressure.The patient was stabilized and transferred to (b)(6) for further treatment.(b)(6) emergency room notes documented an inr of >10.5, pt >121.1 and ptt 89, occult blood in stool, hemoglobin 8.5 and hematocrit 25.3.The following tests were elevated: white blood cell count, glucose, bun, creatinine, liver function and bnp.The hospital medical records documented that a ct scan showed a retroperitoneal hematoma and spontaneous bleeding.The blood pressure stabilized and the dopamine was discontinued.On (b)(6) 2014 at 7:29am the following results were documented: hemoglobin=9.6, hematocrit=27.4 inr was at 1.8.At 1:55pm, the hemoglobin was at 7.4 and hematocrit was 21.3.The patient was given 1 unit of prbc's but developed congestive failure and hypoxemia and required a continuous lasix drip.The patient continued with intermittent hypoxemia and blood pressure was somewhat lower.She refused bipap and supplemental oxygen as well as breathing treatments.The patient and daughter agreed that no further aggressive measures were to be undertaken and the patient was made a dnr.On (b)(6) 2014 the liver function tests showed marked elevation and the inr was reported as 3.4.Additional fresh frozen plasma (ffp) was ordered but refused by the family.Approximately 11:40am, the patient suffered cardiac arrest and straight lined on the telemetry.No resuscitation was performed and she was pronounced dead at 12:04pm on (b)(6) 2014.The final diagnosis was noted as: severe right retroperitoneal bleed, possibly from the kidney but also probably involving the liver.Rule out occult malignancy which is strongly suspected.The death certificate was received and identified the following: immediate cause: sudden cardiac death-ashd; underlying cause: congestive heart disease; multiple blood transfusions.

Manufacturer Narrative

The monitor has been received and the investigation is in progress.

Manufacturer Narrative

Investigation/conclusion: the monitor associated with the complaint was returned for investigation.The strips associated with the complaint were not returned for investigation.Since no lot number was provided for the strips, lot 347475 was used for monitor investigational purposes as it shared the same strip code as the last results on the monitor memory.Investigation of the returned monitor using retained strips for lot 347475 was performed.The customer's complaint was not replicated during in-house testing.There was no product deficiency found for lot 347475.The returned monitor met functional and thermistor testing requirements during investigation.Capa (b)(4) has identified that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to discrepant inr results.A review of the patient's medical records from (b)(6) medical center revealed that the patient had severe anemia and a retroperitoneal bleed.The patient's anemia could not be ruled out as a cause for the discrepant result.Additionally, capa (b)(4) has determined that impedance curves with weak slope change can cause discrepant results.The monitor holds only the last four result curves in the memory and the 3.1 was not one of the results therefore, the impedance curve analysis could not be performed on the 3.1 result.A root cause could not be determined from the information provided by the customer.

• Brand Name: INRATIO2 PT/INR MONITORING SYSTEM
• 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: 4946807
• MDR Text Key: 6033695
• Report Number: 2027969-2015-00465
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/28/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200432
• Device Lot Number: 102604937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2015
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: FLUCONAZOLE (DIFLUCAN) 150MG PRESCRIBED; HYDROCHLOROTHIAZIDE 25MG DAILY; WARFARIN 5MG M/W/F/SAT AND 7.5MG TU/TH/SU; NYSTATIN PRESCRIBED; SIMVASTATIN 40MG DAILY; METFORMIN 500MG DAILY; NIFEDIPINE ER 30MG DAILY; HYDROCODONE/ACETAMINOPHEN (7.5/750MG) 3X DAILY; ALPRAZOLAM 1MG 3X DAILY
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 73