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

Model Number 100139

Device Problem Low Test Results (2458)

Patient Problems Hemorrhage/Bleeding (1888); Skin Discoloration (2074)

Event Date 09/10/2014

Event Type  Injury  

Event Description

Caller alleging receiving a discrepant low inratio value.On (b)(6) 2014: inratio 2.3.On (b)(6) 2014: lab 16.1.Time between tests: two days.Patient's therapeutic range unk, however, caller said the inratio value was within patient's therapeutic range.Caller stated patient had clinical symptoms of bruising and nose bleeds.No additional information provided.Although multiple attempts were made to obtain follow-up treatment and additional patient information, they were unsuccessful.No additional information available.

Manufacturer Narrative

The customer did not provide a lot number or return any products for investigation.Unable to perform further investigation without additional information.Since the product associated with the complaint was not returned, manufacturing record review could not be performed and further investigation was not possible.As there is no indication of a product deficiency, no corrective action is required at this time.

• Brand Name: INRATIO PT/INR TEST STRIP
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4184252
• MDR Text Key: 20777296
• Report Number: 2027969-2014-00923
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2014

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: 100139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/15/2014
• 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 #UNK
• Patient Outcome(s): Other