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

Model Number 100071

Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.

Event Description

The end user's caregiver called to report a variance between the inratio inr result and the laboratory inr result.On (b)(6) 2015, the caregiver called after receiving 8 unspecified error messages on the inratio device.On the 9th test, the inratio inr was 1.6.The following day, (b)(6) 2015, the patient went to a follow up radiation appointment and the laboratory inr was 2.1.The patient has advanced stage cancer.Therapeutic range: 2.0 - 3.0.Reportedly, multiple fingersticks were performed on the same finger, the sample was not immediately applied, multiple drops of blood was applied and the finger touched the sample well.These are all 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 met accuracy criteria and the product performed as expected.The customer's complaint was not replicated.The manufacturing records for the lot were reviewed and the lot met release specifications.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.The customer was reported to have advanced stage cancer.This condition may impact the performance of the assay.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

Clarification: the call was received on (b)(6) 2015 and the inratio error messages and the inratio inr result was performed on (b)(6) 2015.

• 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: 5299685
• MDR Text Key: 34140749
• Report Number: 2027969-2015-01013
• 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: distributor,other
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 370763AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• 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