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

Model Number 200432

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109)

Event Date 10/23/2015

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

The caller alleged a variance between inratio inr result and the lab inr result.The results were as follows: (b)(6) inratio inr=2.6, (b)(6) lab inr=1.2.Patient self tester's therapeutic range is: 2.5-3.5.On (b)(6) 2015 patient self tester suffered a stroke and was taken to the hospital; the lab inr=1.2.The patient self tester remained in the hospital for 22 days.During this time he suffered a second stroke.The caller, wife of patient, could not provide the date of the second stroke.During his time in the hospital, the patient self tester did not test at all using his inratio monitor.Caller was unable to provide further information regarding additional lab tests during this period of time nor could she provide any information regarding treatments administered.On (b)(6) 2015, the patient self tester was considered stable and was released.

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 the monitor as above concomitant medical products: removed the monitor as a concomitant medical product and added the inratio pt/inr test strips.For 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.Donor testing was performed with the returned monitor and retained strips of lot 366218.Lot 366218 was manufactured close to the customer's reported strip lot and was used because the customer's exact lot was depleted prior to investigation.A statistical analysis of the impedance curve associated with an in-house discrepant result determined that the curve exhibited a weak-slope change.Impedance curves with weak slope changes can result in discrepant results.This issue is related to the software on the monitor and was addressed in capa-(b)(4).Functional and thermistor testing were performed on the returned monitor with passing results.With the exception of the weak-slope observed during in-house testing, in-house testing shows that the system is performing within expectations.A review of the entire in-house testing history for strip lot 360632 was conducted.In-house testing on strip lot 360632 meets expectations.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot meets release specification.There was no information identified in the complaint that indicated technique issues, improper storage conditions, or patient sample interference.Root cause cannot be determined from the information provided.Capa-(b)(4) identified impedance curves with weak slopes as potentially leading to discrepant inr values.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 rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5331320
• MDR Text Key: 34524152
• Report Number: 2027969-2015-01029
• 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
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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: 360632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• 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
• Patient Outcome(s): Hospitalization; Life Threatening