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

Model Number 200432

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Stroke/CVA (1770); Death (1802); Headache (1880); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891)

Event Date 01/14/2014

Event Type  Injury  

Event Description

A medwatch form (b)(4), which was completed and submitted to the fda by the patient's husband, was received by alere (b)(4) on 06/03/2015.On (b)(6) 2015, (b)(4) spoke with the patient's husband and obtained the following information: the patient started warfarin in 2010 for atrial fibrillation and started using the inratio device in 2014.(b)(6) 2014: the patient was hospitalized for a scheduled colon surgery related to stage 3 colon cancer.Warfarin was stopped and lovenox was started 1 week prior to the surgery.(b)(6) 2014: the patient stopped lovenox, resumed warfarin and started unspecified antibiotics.It was unknown how long the antibiotics were taken.Per the husband, the patient recovered from surgery but had infections.(b)(6) 2014: inratio inr=2.8 therapeutic range 2.5 - 3.5.(b)(6) 2014: the patient experienced headaches and was taken to the emergency room via ambulance where the laboratory inr was approximately 5.8 (lab is approximated as husband does not have record of exact results but stated that he believed the result was 5.8) warfarin was immediately held but no vitamin k was administered.Testing on (b)(6) 2014 showed "bleeding on the brain and it was determined the patient suffered a stroke".The patient was given morphine for pain.(b)(6) 2014: the patient was transferred to atlanta medical icu, where the "blood was drained off of the brain", plasma and lovenox was administered.The patient was switched to lovenox and never resumed warfarin.The patient remained in icu until she was discharged from the hospital.(b)(6) 2014: the patient was discharged from the hospital and transferred to a rehab nursing facility.(b)(6) 2014: the patient was again hospitalized.The husband was unable to provide the reason for hospitalization.He stated that the patient developed "issues" but could not provide any further information on a specific condition or clarify what the "issues" were.(b)(6) 2014: the patient passed away.The husband did not have her death certificate available but he said that he recalled the cause of death on the death certificate was "respiratory failure related to atrial fibrillation".There is no information available to confirm a malfunction or that the device caused or contributed to the reported events.Based on the inability to rule out the possibility that the device may have caused or contributed to the "bleeding event" and stroke, this event is conservatively reported as a serious injury based on the "bleeding" event and stroke being potentially related to the patient's coagulation status; however, a device deficiency cannot be substantiated.

Manufacturer Narrative

The husband stated that he is not returning the monitor.Medical records have been requested from (b)(6).At this time we have no information that the inratio monitor was used following the (b)(6) 2014 result.Investigation is pending.

Manufacturer Narrative

Conservatively adding "product problem" due to the variance between the historical inratio inr results and the inability to obtain information to determine if a medication change may have caused the variance.Date of event changed to (b)(6) 2014.Investigation/conclusion: it is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.After reviewing all in-house donor testing for lot 334474, no product deficiency was found for this lot.The manufacturing records for the lot were reviewed and the lot met release specifications.Certain relevant conditions have been identified that may contribute to discrepant inr results.Cancer and infections (including viral, bacterial, or sepsis) were identified as conditions that may contribute to a discrepant inr result these conditions may contribute to a discrepant inr result.A notification letter has been sent to customers to inform them of these patient conditions.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 as contributing to potential discrepant results.The root cause is unable to be determined at this time without product return.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

Additional historical inratio inr results received from distributor as follows: (b)(6).

• 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: 4889375
• MDR Text Key: 21776484
• Report Number: 2027969-2015-00455
• 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
• Type of Report: Initial
• Report Date: 06/03/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER UNSPECIFED HEART MEDICATION; UNSPECIFIED ANTIBIOTICS STARTED (B)(6) 2014; WARFARIN STOPPED (B)(6) 2014; INRATIO PT/INR TEST STRIPS 100071, LOT # 334474; DIGOXIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR