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

Model Number 100071

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

Patient Problem Test Result (2695)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio values.(b)(6).

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 the reported strip lot met release criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any non-conformances.The lot met release specifications.Although the customer was identified as having conditions that may impact the performance of the assay, a root cause could not be determined.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• 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: 5763608
• MDR Text Key: 48619754
• Report Number: 2027969-2016-00482
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 373678A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention