MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 99008G1

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Stroke/CVA (1770); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The customer did not provide a lot number or return any products for investigation.Since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.The customer's monitor is expected to be returned; investigation will be performed if/when it is returned.

Event Description

A variance between inratio inr and lab inr results was reported from a customer in germany.The results were as follows: inratio inr = 2,5 hospital lab inr = 1.5.No dates or times were provided; no therapeutic range was available.It was reported that the female patient was hospitalized due to an acute stroke; no further information was available on how the results correlated nor about the female patient.(note: the inratio2 product 99008g1 is not available in the united states; however, this mdr filing is due to a same or similar device being available in the united states.).

Manufacturer Narrative

Investigation/conclusion: further investigation cannot be pursued because there is no lot number and product was not returned.

Manufacturer Narrative

Investigation/conclusion: the number of complaints for this meter type and trend code did not exceed the threshold.The reported meter was returned and investigated in case (b)(4).Functional and thermistor testing was performed on the returned meter with passing results.The meter performed as expected.Further investigation cannot be pursued because there is no lot number.

• Brand Name: INRATIO2 PT/INR TEST STRIPS
• 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: 5923044
• MDR Text Key: 53777947
• Report Number: 2027969-2016-00602
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2016

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: Health Professional
• Device Model Number: 99008G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2016; 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR SN: (B)(4)
• Patient Outcome(s): Hospitalization; Life Threatening