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

Model Number 100071

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.

Event Description

The following information was reported via telephone call on (b)(6) 2016.Results are as follows: date: (b)(6) 2016, inratio inr: 2.0; (b)(6) 2016, 2.1; (b)(6) 2016, 1.4 and 1.6 (<15 minues apart).Therapeutic range: 2.0 - 3.0.Reportedly, multiple finger sticks were performed on the same finger and multiple drops of blood added to the sample well.This is considered to be improper techniques when performing the inratio test.There was no reported adverse patient sequela.There was no additional information provided.

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 strip testing on the reported strip lot meets accuracy criteria.The product performed as expected.The customer's complaint was not replicated.Although a relevant nc was noted in batch record, it did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.The customer did not provide a laboratory alternative testing method result for the reported inratio value.It is not possible to verify if a discrepancy exists without this information.Although the root cause analysis did not include return testing, improper techniques were identified in the complaint.These could not be ruled out as a cause of the unexpected results.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 (Section G): 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: 5613516
• MDR Text Key: 44494425
• Report Number: 2027969-2016-00269
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 382527A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2016
• 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