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

Model Number 99008G1

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: further investigation to determine whether the product failed to meet specifications cannot be pursued because the customer did not provide a serial/lot number.The root cause cannot be determined due to insufficient information.No corrective action is required.

Event Description

Report received from patient's daughter-in-law.Event occurred in (b)(6).Reportedly, patient had a stroke on (b)(6) 2016 and is hospitalized.The daughter-in-law indicated the patient did not test himself for a longer period, due to a lack of test strips.Patient's therapeutic range unknown.No additional information provided.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The customer could not provide information regarding details of the event.This event is conservatively reported due to alleged deficiency that cannot be substantiated without access to additional data or results.

• 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: 6189805
• MDR Text Key: 62846750
• Report Number: 2027969-2016-00708
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

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: 99008G1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR SERIAL #(B)(4)
• Patient Outcome(s): Life Threatening
• Patient Age: 86 YR