MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO 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 Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); Test Result (2695)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant high inratio inr values compared to coaguchek and laboratory event occurred in (b)(6).Patient's therapeutic range not provided (b)(6).Patient was hospitalized because of bleeding from (b)(6) 2016.No inr values were reported during hospitalization.Although requested, no additional information was provided relating to hospitalization.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.The reported lot was investigated as part of fi-16-011.Investigation identified an issue with sample collection that led to increased discrepant results during donor testing.Reevaluation of the lot based on this investigation shows the lot to be performing as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Unable to determine the root cause of the customer's complaint.

• 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: 5706717
• MDR Text Key: 46828561
• Report Number: 2027969-2016-00427
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 99008G1
• Device Lot Number: K382422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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