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

Model Number 200432

Device Problem Low Test Results (2458)

Patient Problems Fall (1848); High Blood Pressure/ Hypertension (1908); Dizziness (2194)

Event Date 08/09/2015

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Patient self tester called alleging discrepant inratio values.Patient's therapeutic range 2 - 3.(b)(6) 2015 patient self tester went in for scheduled shoulder surgery.Prior to the surgery, he stopped warfarin and was switched to lovenox for the procedure.The patient was unable to provide the exact time frame.Following surgery, patient was bridged back onto warfarin and given hydrocodone.Patient stated the lovenox was stopped on (b)(6) 2015 and he resumed his normal warfarin dose of 6mg daily.Patient continued to take hydrocodone until (b)(6) 2015, no dose available.(b)(6) 2015 patient self tester was experiencing dizzy spells and called his physician regarding symptom.Physician advised to test inr using inratio, inratio = 2.1.Dizzy spells continued and patient experienced a couple falls.Per patient, there was no injury during falls but patient decided to go to the hospital due to symptoms.Patient went to (b)(6) hospital in (b)(6) (per patient may not be the current name).He was admitted to the hospital for pulmonary hypertension.Patient had lab inr (venous draw) taken 3-4 hours after inratio test, lab = 6.9.Patient was given vitamin k and warfarin was held (last dose - (b)(6) 2015 evening).(b)(6) 2015 lab = 2.9.Patient self tester was hospitalized from (b)(6) 2015.During hospitalization, he underwent cardiac catheterization.Patient stated this was in response to the pulmonary hypertension.Patient did not want to provide any additional information regarding hospitalization, but did state that his pulmonary hypertension went from mild to more severe.Patient resumed warfarin on (b)(6) 2015 and was released to home (b)(6) 2015.Patient was unable to provide discharge diagnosis.No additional information provided.

Manufacturer Narrative

Brand name: removed inratio pt/inr test strips (as the complaint device) and added the inratio2 pt monitoring system (monitor).Model #: removed inratio pt/inr test strip and added the monitor model (b)(4).Lot#: removed inratio pt/inr test strip lot number and included serial number of monitor as above removed the monitor as a concomitant medical product and added the inratio pt/inr test strips.Pma 510k#: removed the inratio pt/inr test strip 510k# k092987 and added k072727 to reflect the inratio2 pt monitoring system.Labeled for single use?: changed from "yes" to "no" since the monitor is not a single use device usage of device: changed from "unknown" to "reuse" since the monitor is not a single use device.Investigation conclusion: the monitor and strips associated with the complaint were returned for investigation.The customer's complaint was not confirmed during in-house testing.Returned and retained strips tested on the returned meter met accuracy criteria.After reviewing the entire in-house testing history for lot 364994a, no product deficiency was found for this lot.Functional and thermistor testing were performed on the returned meter with passing results.The meter performed as expected during in-house investigation.Although relevant nc's were noted in batch record, it did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.The impedance curve associated with the customer's inratio inr result was analyzed statistically.The impedance curve associated with the reported 2.1 result was found to exhibit weak-slope change.Capa investigation (capa-(b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.No patient conditions were provided by the customer to determine if these led to the weak slope change observed.There are no known medical conditions provided by the customer that would interfere with the test.An impedance curve with weak-slope change has been identified in capa-(b)(4) to contribute to a potential discrepant result.Further investigation is being performed under capa-(b)(4) for this issue.

Manufacturer Narrative

Investigation/conclusion updated: the meter and strips associated with the complaint were returned for investigation.There were not enough retained and return strips from the complaint lot to complete testing of the returned meter; therefore a strip from lot 365013 was used for the investigation as this originated from the same brick as lot 364994a.The customer's complaint was not replicated.Retained and returned strips tested on the returned meter met accuracy criteria.Functional and thermistor testing were performed on the returned meter with passing results.The system performed as expected.A review of the entire testing history for the lot number 364994a was performed.In-house testing on strip lot 364994a meets criteria.The manufacturing records for the lot 364994a were reviewed.Although relevant nc's were noted in batch record, it did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.The impedance curve for the customer's result of 2.1 was statistically analyzed and was found to exhibit a weak-slope change.Capa investigation (capa-(b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.There are no known medical conditions provided by the customer that would interfere with the test.An impedance curve with weak-slope change has been identified in capa-(b)(4) to contribute to a potential discrepant result.Further investigation is being performed under capa-(b)(4) for this issue.

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): 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: 5064664
• MDR Text Key: 25290079
• Report Number: 2027969-2015-00658
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 08/14/2015

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: 364994A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/17/2015; 04/25/2016
• 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: HYDROCODONE
• Patient Outcome(s): Hospitalization; Required Intervention