MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO 2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 2004I32

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

The monitor associated with the complaint was returned for investigation.No strip lot number was provided by the customer.A statistical analysis of the impedance curve associated with the customer's result 2.5 found that the curve exhibited a weak slope and 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 meter 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.No patient conditions were provided by the customer to determine if these led to the weak slope change observed.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.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) for this issue.

Event Description

On (b)(6) 2016, a patient reported a variance between an inratio inr result of 2.5 on (b)(6) 2016 and an unknown test method inr result of 8.3 on (b)(6) 2016 (reported therapeutic range 2-3) at (b)(6) medical clinic upon experiencing an intense headache.The patient was taken across the street to (b)(6) hospital where a ct scan was performed.The scan showed a subdural hematoma bleeding into the patient's brain.The patient was then transferred and admitted to (b)(6) medical center hospital for treatment which included vitamin k and plasma.Note, the patient reportedly called alere on (b)(6) 2016, was informed of the inratio recall and stated "that information never reached me or my doctor," however, records reviewed by an alere technical service specialist indicate that both the patient and doctor had been notified on (b)(6) 2015 respectively.The patient's inratio monitor was replaced with a coaguchek xs monitor.

Manufacturer Narrative

A strip lot number was not provided by the customer and therefore was not included on the initial medwatch report.A review of the monitor memory was performed and strip lot number 367839a was identified as the lot used by the customer.A review of the entire in-house testing history of strip lot 367839a was performed; the lot meets the release specification for the product.The manufacturing records for the lot were reviewed; the lot met release specifications.

• Brand Name: INRATIO 2 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: 5701094
• MDR Text Key: 46620663
• Report Number: 2027969-2016-00419
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

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: 2004I32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• 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; Required Intervention