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

Model Number 100071

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Anemia (1706); Death (1802); Transient Ischemic Attack (2109)

Event Date 10/13/2014

Event Type  malfunction  

Event Description

On 03/13/2015 a phone call was received from the patient's daughter with concerns that the inratio monitor results her mother had received were inaccurate.The following is a chronological history of information provided.(b)(6).Patient's therapeutic range 2.0 - 2.5.The patient entered the hospital on (b)(6) 2014 and died on (b)(6) 2014.The daughter believes that her mother's death was due to a stroke.Though requested, the daughter had no information available regarding treatment, interventions provided, hospital inr or any medication dosage information.Daughter stated her mother was anemic and had c.Diff the week prior to her death.There is no information to suggest that the inratio caused or contributed to the subsequent event.

Manufacturer Narrative

Investigation conclusion: 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.

• 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: 4673463
• MDR Text Key: 19608402
• Report Number: 2027969-2015-00257
• 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: Other
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/09/2015
• 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: FUROSEMIDE; POTASSIUM CHLORIDE; LISINORPIL; METOPROLOL; INRATIO MONITOR SERIAL #(B)(4); ECOTRIN; WARFARIN; LIPITOR