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

Model Number 100071

Device Problems Low Test Results (2458); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/27/2014

Event Type  Injury  

Manufacturer Narrative

Investigation/conclusion: 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 alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "personal injury" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.If additional information is received, a supplemental medwatch form will be completed and submitted.

Event Description

This event was identified as part of an evaluation in which insurance claims/filed suits communicated to alere legal had not been forwarded to alere (b)(4) for investigation.There is limited information available regarding the event and due to the time gap between when the complaint was first reported to when asd was notified, additional information is not available.Complainant alleged "personal injury in connection with use of the inratio2 meter." there were no inr results, event description or event date reported.Historical information received from alere home monitoring, inc.(ahm).The patient did not report any result issues or injury events to ahm between (b)(6) 2013 and (b)(6) 2014.The patient was discharged from ahm services on (b)(6) 2014.There was no reason provided as to why the service was stopped.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 alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "personal injury" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.

Event Description

Initial mdr:this event was identified as part of an evaluation in which insurance claims/filed suits communicated to alere legal had not been forwarded to alere (b)(4) for investigation.There is limited information available regarding the event and due to the time gap between when the complaint was first reported to when (b)(4) was notified, additional information is not available.Complainant alleged "personal injury in connection with use of the inratio2 meter." there were no inr results, event description or event date reported.Historical information received from alere (b)(4).((b)(4)).The patient did not report any result issues or injury events to (b)(4) between (b)(6) 2013 and (b)(6) 2014.The patient was discharged from (b)(4)services on (b)(6) 2014.There was no reason provided as to why the service was stopped.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 alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "personal injury" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.Follow-up #1 mdr: additional information received as follows: historical inratio inr results: (b)(6) 2014: 1.7.(b)(6) 2014: 2.0.(b)(6) 2014: 1.9.Therapeutic range: 2.3 - 3.7.When inratio inr reading was low, the patient would take a double dose of coumadin.The patient has pre-existing medical conditions but none specified.The patient was hospitalized on (b)(6) 2014 and was on antibiotics at the time of her hospitalization.There was no diagnosis provided, no inratio inr results at time of hospitalization or laboratory inr results, but indicated in the below statement "extreme blood loss".In (b)(6) 2015, it was reported that the patient has been treating with a rheumatologist due to severe joint paint that has developed since the (b)(6) 2014 hospitalization.Reportedly, the patient's ability to walk diminished at the time of the hospitalization and she had to re-learn how to walk."the rheumatologist believes her current condition is correlated to the extreme blood loss that she experienced in (b)(6) 2014." there was no additional information provided.

Manufacturer Narrative

Correction: new information was received on 05/16/2018.The following sections have been updated to reflect the new information: (report type) updated to include adverse event and product problem.(outcomes attributed to adverse event) updated to include hospitalization - initial or prolonged, required intervention to prevent permanent impairment/damage (devices), and other serious (important medical events).(describe event or problem) updated to reflect additional information.(other relevant history, including preexisting medical conditions) updated to reflect additional information.(event problem and evaluation codes) device code updated to 2458.

Event Description

Following a heart surgery, the patient began using the inratio inr system in 2008.On or around on (b)(6) 2014, the patient sought treatment at her primary care provider's office for musculoskeletal pain that started within the previous 30 days.The patient had no history of joint pain and three diagnostic impressions were subsequently taken.The physician only noted osteopenia, which the physician noted is "common in post-menopausal women" like the patient.The physician's final impression was that the symptoms were "suggestive of rheumatoid arthritis." the patient reported three low inratio inr results following this appointment: on (b)(6).The patient's therapeutic range was initially reported as 2.3 to 3.7 but later clarified to be 2.4 to 3.6.On or around on (b)(6) 2014, the patient was admitted to the emergency room by ambulance after her primary care physician examined her and discovered acute symptom, including purple nose, bleeding from the mouth, blood in her urine, facial swelling and a hematoma under the tongue.Additionally, the patient experienced bleeding under her skin near her throat, arms and legs.The patient's chief complaint was of coughing up blood for a week and throat swelling among the doctor's impression.The patient's inr was tested in the emergency room at 4:30pm and again at 6:15pm with laboratory inr results of 33 and 33.The patient underwent at least seven blood tests within 48 hours.The impression was coumadin coagulopathy, hematuria, and acute renal failure.On (b)(6) 2014, the patient's inr normalized.The patient's bleeding under the skin near her throat, arms, and legs continued for several months after her hospitalization.In october 2015, it was reported that the patient had been treated by a rheumatologist due to severe joint paint that had developed since the may 2014 hospitalization.Reportedly, the patient's ability to walk diminished at the time of the hospitalization and she had to re-learn how to walk."the rheumatologist believes her current condition is correlated to the extreme blood loss that she experienced in may 2014.".

• 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
• MDR Report Key: 5096319
• MDR Text Key: 26468057
• Report Number: 2027969-2015-00692
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Followup,Followup
• Report Date: 06/15/2018

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: 100071
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Supplement Dates Manufacturer Received: Not provided; 05/16/2018
• Supplement Dates FDA Received: 12/16/2015; 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR SN: (B)(4).
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR