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

Model Number HS99008G1

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

Patient Problem Test Result (2695)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Event occurred in (b)(6).Report of discrepant inratio inr value: on (b)(6) 2016 inratio inr = 7.5; pathology inr = 4.9.Patient's therapeutic range 2 - 3.It was reported the patient was sent to the hospital and their warfarin dose was dropped.Although requested, no additional information provided regarding hospitalization.

Manufacturer Narrative

Additional information: (b)(6) 2016 inratio inr = 3.4; pathology inr = 3.0.Investigation pending.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house testing on strip lot k381677 was found to be performing within expectations.A review of the manufacturing records for lot k381677 did not uncover any non-conformances.Root cause cannot be determined from the information provided.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 road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5535478
• MDR Text Key: 41470536
• Report Number: 2027969-2016-00202
• 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,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2016

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: HS99008G1
• Device Lot Number: K381677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2016; 04/25/2016
• 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
• Treatment: INRATIO MONITOR SERIAL #(B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention