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

Model Number 200432

Device Problem High Test Results (2457)

Patient Problem Myocardial Infarction (1969)

Event Date 07/19/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

On (b)(4) 2015, a phone call was received from the distributor and transferred to alere (b)(4).The caller alleged a variance between the inratio inr results, the laboratory inr result and a point of care (poc) inr result.On (b)(4) 2015, the patient tested on the inratio and obtained an inr of 3.8, which was reported to his physician.The therapeutic range was 2.0-3.0.The patient did not state that any changes were made to his warfarin dose after this result was obtained.On (b)(4) 2015, the patient tested on the inratio and obtained an inr of 3.3, which was reported to his physician.His physician decreased his warfarin from a daily dose of 5mg to 2.5 mg on (b)(4) 2015 and (b)(4) 2015.He was ordered to continue warfarin 2.5 mg on mondays and fridays and warfarin 5mg the rest of the week.On (b)(4) 2015, the patient suffered a "heart attack" and was taken, by ambulance, to the hospital where he suffered another heart attack.The laboratory inr was 1.2.Treatment included intravenous (iv) heparin.The patient was diagnosed with a heart blockage and underwent a stent placement.On (b)(4) 2015, the laboratory inr was 1.1 and iv heparin was continued.On (b)(4) 2015 the patient was discharged from the hospital and prescribed nitrostat as well as other medications (names and doses not provided).The patient was unable to confirm his inr before being discharged.On (b)(4) 2015, the distributor transferred a call from the patient to asd.The physician had suggested another correlation to be performed and a visiting nurse was sent to the patient's home to perform testing.The nurse performed two separate finger-sticks for testing.The inratio inr was 1.2, and the nurse's point of care (poc) inr was 1.1.The patient stated that he was still concerned about the difference in results.There was no additional information provided.

Manufacturer Narrative

Corrections: brand name: removed inratio pt/inr test strips (as the complaint device) and added the inratio2 pt monitoring system.(monitor): d4 model #: removed inratio pt/inr test strip and added the monitor model 200432.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.G5 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 associated with the complaint was returned for investigation.Since lot# 355401 was depleted, lot# 355402 was utilized for the investigation.Lot#355402 is identical to 355401 except for the outer packaging and labeling.Therapeutic and normal donor testing was performed on the returned monitor using 355402 retained strips.The testing history and manufacturing records for ots 355401 and 355402 were reviewed and the lots met release specifications.Impedance curve analysis was performed on the customer's reported inratio values of 1.2, 3.3, and 3.8.The impedance curves associated with inratio values of 1.2 and 3.3 appeared normal in shape, while the impedance curve associated with inratio value of 3.8 was associated with an abnormal slope change.Our capa investigation (capa-(b)(4)) has determined that impedance curves with abnormal slope change can cause discrepant results.Further investigation has been performed under capa-(b)(4).

• 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 (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: 5014899
• MDR Text Key: 23515744
• Report Number: 2027969-2015-00600
• 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,distributor
• Reporter Occupation: Patient
• Remedial Action: Recall
• Report Date: 07/28/2015

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: 355401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention