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

Model Number 100071

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Myocardial Infarction (1969); Respiratory Distress (2045); Thrombus (2101)

Event Date 07/31/2012

Event Type  Death  

Event Description

On 03/30/2015, a phone call was received from the patient's wife after she received the alere inratio pt/inr monitor system urgent medical device correction notification, dated december 05, 2014.She reported that her husband expired, in 2012 (date of death: (b)(6) 2012 per (b)(6) obituary), due to a blood clot around his mechanical heart valve which caused respiratory distress and a heart attack.In addition, she believes the monitor was giving incorrect readings around the time of his death.The only information, that the wife could provide, was an inratio result of 1.X (the exact result and date were unknown.Additional inr data from the distributor was obtained as below).The wife reported that the inratio results were consistently lower than the laboratory results; however, in another statement, she reported that no laboratory comparisons were ever performed since they were relying solely on the inratio readings.The patient's therapeutic range was 2.5 - 3.5.The distributor, (b)(4), was contacted in an attempt to obtain additional information.The following is a chronological history of available information and inratio inr results.(b)(6) 2012: inratio inr=2.1, (b)(6) 2012: inratio inr=1.8, (b)(6) 2012: inratio inr=2.5, (b)(6) 2012: inratio inr=3.3, (b)(6) 2012: inratio inr=2.3, (b)(6) 2012: inratio inr=3.3.Though requested, there was no additional information provided.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 death and two weeks prior to the event.The coagulation status can significantly change during this period of time and there was no laboratory reference value.The patient's wife could not provide information regarding details of the event.Additionally, she provided contradictory information regarding laboratory results as well as information about inratio results which were not consistent with confirmed results from ahm on the monitor.Based on the inability to rule out the possibility that the device may have caused or contributed to the death, this event is conservatively reported as a death based on the blood clot being potentially related to the patient's coagulation status, however, a device deficiency cannot be substantiated.

Manufacturer Narrative

Investigation/conclusion: the patient's wife did not provide a lot number or return the device 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 death and two weeks prior to the event.The coagulation status can significantly change during this period of time and there was no laboratory reference value.The patient's wife could not provide information regarding details of the event.Additionally, she provided contradictory information regarding laboratory results as well as information about inratio results which were not consistent with confirmed results from ahm on the monitor.Based on the inability to rule out the possibility that the device may have caused or contributed to the death, this event is conservatively reported as a death based on the blood clot being potentially related to the patient's coagulation status, however, a device deficiency cannot be substantiated.

Manufacturer Narrative

Investigation/conclusion updated: since the spouse was unable to provide the inratio testing strip lot number, asd contacted the supply distributor and was able to obtain three (3) lot numbers that were supplied to the patient from (b)(6) 2011 through 2012.Manufacturing records for those lot number (282260 expiration date 07/31/2013), 270497 expiration date 12/31/2012 and 270162 expiration date 12/31/2012 were reviewed and the lot met release specifications.Additionally, a review of the last in-house testing data was performed.The retain strips met accuracy and precision criteria at the time testing was performed.The product performed as expected and no product deficiencies were observed capa investigation (capa-(b)(4)) has determined that certain relevant conditions (e.G.Low hematocrit, sepsis) can contribute to discrepant inr results.Medical records from the hospital show a diagnosis of end stage renal disease with hemodialysis three times a week, c.Difficile colitis and septic shock with bilateral pneumonia.This capa has identified end stage renal disease patients requiring hemodialysis, acute inflammatory conditions and infections as conditions that may contribute to a discrepant inr result.Since the monitor was not returned, the impedance curve associated with the discrepant result could not be analyzed for characteristics of a weak-slope change.An impedance curve with a weak-slope change has been identified in capa-(b)(4) to contribute to a potential discrepant result.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The hospital records were received from doctors community hospital where the patient was hospitalized at the time of his death.Review of records revealed the following: the patient was hospitalized on (b)(6) 2012.The laboratory inr was 2.29, hemoglobin was 10.2 and hematocrit was 31.8.Emergency room notes: chief complaint: difficulty breathing stated complaint: sob, pains in stomach, yellow bowels initial comments: (b)(6) y/o male with past medical history of hypertension, end stage renal disease on hemodialysis (hd) m/w/f, last hd on friday and s/p heart valve replacement on warfarin, 2 days of cough productive yellow sputum, diarrhea, constant and diffuse cramping abdominal pains, diffuse chest pains and foley catheter.Abdominal and chest pains worse with coughing.Patient was recently hospitalized for c.Difficile colitis and had completed a 10 day course of flagyl.Cardiovascular: non-stemi: the patient had elevated cardiac biomarkers without ekg evidence of an stemi.Thrombolytic or transfer for emergent ptca was not indicated.No specific signs or symptoms of pneumonia, myocardial infarction, pulmonary embolism, dissection or pericarditis present.No aspirin or plavix given as patient was therapeutic on warfarin.Patient given antibiotics for productive cough, abdominal pain and possible recurrence of c.Difficile colitis.Given positive biomarkers, patient was admitted to imcu for close observation, though presence of diffuse abdominal pain, chest pain with coughing not consistent with typical acute coronary syndrome.Clinical impression: acute coronary syndrome (acs, mi), colitis, acute bronchitis, fever, dehydration, chronic renal failure syndrome, anemia of chronic renal failure.Cardiac consult on (b)(6) 2012: impression: flat increased troponin with creatinine of 9.0, not typical of non-st elevation myocardial infarction.Congestive heart failure with bnp of 4112 and possible superimposed with pneumonia.Mechanical prosthetic aortic replacement on 5/6/2010 at (b)(6) hospital for aortic insufficiency.Echocardiogram showed mild regurgitation, mean gradient of 17 mmhg across the prosthetic aortic valve on (b)(6) 2012.End-stage renal disease, on hemodialysis.Hypertensive cardiovascular disease.Discharge summary: patient had a code blue.He was transferred to the icu and intubated.Despite antibiotic and mechanical ventilation, the patient coded again and went on the pulseless electrical activity.Cpr and all efforts did not work.The patient was deceased and pronounced dead on (b)(6) 2012 at 1:47 a.M.Discharge diagnosis: septic shock with bilateral pneumonia.Acute hypoxic respiratory failure.Non-st elevation myocardial infarction.End-stage renal disease.Prosthetic heart valve.

• 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 ; 8588052084
• MDR Report Key: 4738574
• MDR Text Key: 5706852
• Report Number: 2027969-2015-00303
• 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,Distributor,distributor,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• 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
• Date Manufacturer Received: 07/28/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 56 YR