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

Model Number HS99007G1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); Test Result (2695)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

A report was received from australia that discrepant low inratio result was observed on (b)(6) 2016.The inratio inr=1.4; cardiologist was notified and it was advised that the patient be hospitalized.Patient was infused over night with heparin.On (b)(6) 2016 inratio was tested twice against hospital poc test and the lab.Inratio result 1.3, inratio result 1.8, poc inr test result 2.2, lab result of 2.6.Case was updated on april 8, 2016: (b)(6) 2016, inratio result: 4.4, poc inr test: 3.5.(b)(6) 2016, inratio result: 3.7, poc inr test: 3.1.(note: the inratio2 product hs99007g1 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

Correction: on the initial mdr it was indicated that this was an adverse event due to the hospitalization and required intervention of the patient on (b)(6) 2016 for an inratio inr=1.4.This should have been a malfunction only since the there was no alternate test method performed and the actions taken were appropriate for the inr observed.There was nothing to indicate that the inratio inr=1.4 was incorrect.Investigation/conclusion: it is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, in-house testing was performed on strip lot k385431.The customer's complaint was replicated during in-house investigation.Although a discrepant result was observed, the testing shows that the system is performing within expectations.A review of the manufacturing records for the lot did not uncover any non-conformances.Lot met release specifications.A root cause could not be determined from the available information.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: 5605930
• MDR Text Key: 43588934
• Report Number: 2027969-2016-00248
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

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: HS99007G1
• Device Lot Number: K385431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention