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

Model Number 99008G1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

Patient Problems Stroke/CVA (1770); Paralysis (1997); No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

Customer in (b)(4) reported a variance between inratio inr results and lab inr results.The results were as follows: (b)(6) 2016; inratio inr=3.6; lab inr=2.3.(b)(6) 2016: inratio inr=4.5; lab inr=2.9.The reported therapeutic range was: 2.5-3.5.The customer stated that on (b)(6) 2016, patient was hospitalized due to a stroke.An unspecified paralysis has receded; patient was to leave the hospital on (b)(6) 2016.Prior to the hospitalization, the patient did regular comparison testing with her physician and the result were comparable; no details were known except that the comparison testing was performed in the lab.An update was received with the following: (b)(6) 2016; lab inr=3.0 - phenprocoumon dosage reduced.(b)(6) 2016; inratio inr=4.0.(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

The monitor associated with the complaint was returned for investigation.The reported strip lot had expired prior to the investigation; therefore, retained strips of lot k388420 were used to test the performance of the monitor.Retained strips tested on the returned monitor met release criteria.The returned monitor met functional and thermistor testing requirements during the investigation.No product deficiencies were observed and the system performed as expected.The customer's results were located in the monitor memory; however, the customer may have reported incorrect dates of occurrence.Impedance curve analysis could not be performed on the reported results because only the last 4 impedance curves can be retrieved from the monitor memory.The customer's results were not found within the last 4 impedance curves.A review of the entire in-house testing history for lot k379138 was performed.Strip lot k379138 has been tested in-house with 48 retained strips.All results met accuracy criteria.The product performed as expected.A review of the manufacturing records for strip lot k379138 did not uncover any non-conformances.The lot met release specifications.The customer was reported to have rheumatic disease and an acute bladder infection; these conditions may impact the performance of the assay.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• 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: 5776367
• MDR Text Key: 49674622
• Report Number: 2027969-2016-00496
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

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: 99008G1
• Device Lot Number: K379138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2016
• 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
• Patient Sequence Number: 1