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 Test Result (2695); No Information (3190)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

It was reported via telephone call that on (b)(6) 2016, the patient's inratio inr was 1.1.The patient's therapeutic range was 2.0 - 3.0.After the inratio inr result was reported to the physician, the physician requested that the patient have a laboratory inr drawn for comparison.The laboratory inr was 5.1.The time between testing was six (6) hours.The patient was hospitalized for elevated inr.At this time, no additional information is known.

Manufacturer Narrative

Please make the following corrections: correct brand name to read: inratio2 pt monitoring system.Correct model and lot # to read: model #200432.Change concomitant medical products from "inratio monitor sn (b)(4)" to "inratio pt/inr test strips, model #100071".Correct pma# to read: k072727.Conclusion: the monitor associated with the complaint was returned for investigation.A statistical analysis of the impedance curve associated with the customer's result of 1.1 found that the curve exhibited an abnormal shape.Capa investigation (capa (b)(4)) has determined that impedance curves with weak slope change and an abnormal shape can cause discrepant results.The inratio monitor software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.The capa investigation has also determined that certain patient conditions can contribute to weak slope change impedance curves.There are no known patient conditions provided by the customer that would lead to the observed weak slope change.Donor testing was not pursued due to the software issue being identified as the root cause of the customer's discrepant results.The returned monitor met functional and thermistor testing requirements.A review of the entire testing history for lot 378770a was performed.In-house testing on strip lot 378770a meets release criteria.The manufacturing records for the lot 378770a were reviewed and did not uncover any non-conformances.Lot met release specifications.Capa (b)(4) identified impedance curves with weak slopes and abnormal shapes as potentially leading to discrepant inr values.Further investigation is being 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: 5567318
• MDR Text Key: 42413487
• Report Number: 2027969-2016-00220
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

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: 378770A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization