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

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.As the customer was unable to provide a lot number, a manufacturing record review and testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.However, internal capa (b)(4) had been opened to investigate significantly lower inratio inr results than the reference result.

Event Description

Patient first received the inratio system in 2008.Patient's therapeutic range is 2.0-3.0.On (b)(6) 2013: patient requested assistance setting strip code in inratio meter and testing.Inratio inr result of 3.0 received.On (b)(6) 2015: patient unable to provide results but stated the results were within therapeutic range.In (b)(6) 2015: patient reported becoming sick with no diagnosis.The patient stated inratio inr results were within therapeutic range.On (b)(6) 2015: patient went to hospital.Laboratory inr result was "close to 8" and the patient was hemorrhaging internally.The patient was administered painkillers and steroids and taken completely off of warfarin.Blood transfusions were performed on the patient.Due to the hemorrhaging, a hematoma collected in the patient's back where previous surgeries had been performed.The physician was hesitant to surgically remove hematoma and prescribed the steroids in with the intention of alleviating the clot.The patient's spinal cord was exposed and all of the sacral nerves crushed.The patient reported being unable to walk for nine days and the sensory nerves disrupted/destroyed from the waist down.The patient was discharged from the hospital after approximately ten days and was transferred to a nursing home.In (b)(6) 2015: patient reported that the physician did not check the colon properly and the patient was re-admitted to the emergency room.The patient stayed four to five days until intestinal compaction stabilized.In 2016: after nearly completing rehab, it was discovered the hemorrhage had travelled downward and collected into hardware in the bone.The hardware in the patient's spine became a site for additional infection.The patient developed an infection in lumbar spine and the infection grew over a couple of months until it "blew out of" the bottom of the patient's back in (b)(6) 2016.Four additional surgeries were performed and the hardware in the patient's spine had to be removed.

Manufacturer Narrative

Additional information: additional information was received on 08/24/2018 regarding the reported events.(describe event or problem) was updated to incorporate the additional information.These events are no longer considered a reportable serious injury or malfunction as information suggests the events were a result of a warfarin potency change, prescription of cipro, and physician negligence.Given the additional information, there is insufficient information to reasonably suggest the inratio system caused or contributed to the reported injury or a device malfunction occurred.Correction: (type of reportable event): these events are no longer considered a reportable serious injury or malfunction as information suggests the events were a result of a warfarin potency change, prescription of cipro, and physician negligence.Given the additional information, there is insufficient information to reasonably suggest the inratio system caused or contributed to the reported injury or a device malfunction occurred.However, this is a mandatory field that requires an entry.Therefore, serious injury has only been selected to represent the type of reportable event for the initial report.

Event Description

Additional information was received on 08/24/2018 regarding the reported events.Below is an updated summary of the events incorporating the additional information: the patient first received the inratio system in 2008.The patient's therapeutic range was 2.0-3.0.In (b)(6) 2015, the patient believes his supplier of warfarin changed.The name of the manufacture and/or supplier of warfarin is unknown.However, the patient alleges that unbeknownst to him he was receiving warfarin of a different potency and as a result his blood was becoming thinner than recommended.Ultimately, this contributed to the patient developing an internal hemorrhage and experienced a permanent injury.In (b)(6) 2015, the patient stated inratio inr results were within therapeutic range.However, at some point during the month, the patient was feeling ill and presented for treatment at his physician's office.In the first evaluation the physician ordered a blood panel.When the patient's condition did not improve he presented for a second evaluation.At that second evaluation the physician decided to prescribe the patient cipro.Per the patient, cipro is a very powerful drug known to interact with the liver.The patient later discovered one of the side effects in its interaction with warfarin is to rapidly accelerate the blood thinning effect of warfarin.Per the patient, this was the effect of the cipro.The patient alleges that as a direct result of the negligence of the primary care physician the thinness of his blood was accelerated to such a level that resulted in an internal hemorrhage.On or about (b)(6) 2015, the patient was suffering from pain and gradual numbness in his lower extremities.He presented to the emergency room.At that time it was discovered that as a result of his blood reaching a dangerously thin level he had been bleeding profusely internally.The laboratory inr result was "close to 8." he was hospitalized and provided with numerous blood transfusions.Approximately two days later, a lumbar mri was done.The patient believes that the physicians discovered that a hematoma had formed in his lower spine while at the emergency room.The patient alleges that the physicians failed to discuss the surgical option to relieve the hematoma and pressure on the nerves in his lower spine during the critical window of time.The subsequent permanent damage to his sacral nerves may have been avoided or alleviated in whole or in part.The patient suffered permanent injury to lower extremities, bowel, and bladder function.These events are no longer considered a reportable serious injury or malfunction as information suggests the events were a result of a warfarin potency change, prescription of cipro, and physician negligence.Given the additional information, there is insufficient information to reasonably suggest the inratio system caused or contributed to the reported injury or a device malfunction occurred.

• 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: 6363262
• MDR Text Key: 68466022
• Report Number: 2027969-2017-00041
• 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: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: 08/24/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: INRATIO PT MONITOR, PN 100007, SERIAL# (B)(6); INRATIO PT MONITOR, PN 100007, SERIAL# (B)(4)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR