MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problem No Apparent Adverse Event (3189)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 12/01/2016

Event Type  Death  

Manufacturer Narrative

Investigation conclusion: the meter associated with the complaint was returned for investigation.In-house testing on the returned meter using retained test strips met accuracy criteria.The customer's complaint was not replicated.The returned meter passed functional and thermistor testing requirements during in-house investigation.The system performed within expectations.A lot number was not provided by the customer and therefore a review of manufacturing records could not be conducted.The meter memory was reviewed and the (b)(6) 2016 inratio inr result of 2.1 as reported by the wife was not located.The last result located in the meter memory is an inr result of 1.37 on (b)(6) 2016.A statistical analysis of the impedance curves generated using the last 4 inratio inr results stored in the meter memory determined that one of the curves exhibited a weak-slope.The customer was unable to confirm which result was in question, therefore the curve with the weak-slope could not be confirmed as the customer's complaint result.Weak-slope changes can contribute to discrepant results.This issue is related to the algorithm software on the meter and was addressed in a capa.

Event Description

The patient's wife called in response to inratio system withdrawal notification.The wife provided last historical inratio inr result of 2.1 on (b)(6) 2016.Although the wife was unable to provide a therapeutic range for the patient, she stated this result was in range.On (b)(6) 2016: patient suffered a major stroke, was administered a clot buster, and experienced a second stroke.Patient died due to acute cva with hemorrhagic conversion due to or as a consequence of iv tpa and atrial fibrillation.No additional information available.Although a device deficiency cannot be substantiated, this event is being conservatively filed.

• Brand Name: INRATIO PT/INR TEST STRIPS
• 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: 6309563
• MDR Text Key: 66760106
• Report Number: 2027969-2017-00028
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• 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
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• 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-2354,2362-2016
• Patient Sequence Number: 1
• Treatment: INRATIO 2 PT MONITOR, PN 200432, SERIAL# (B)(4)
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR