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

Model Number 99008G1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.

Event Description

A physician's office in (b)(6) reported a variance between inratio2 inr result and laboratory inr result.Results are as follows: date: not provided, inratio2 inr: >7.5, laboratory inr: 2.9.Therapeutic range: not provided.Testing was performed one after the other.Reportedly, the finger was "milked" after the finger stick.This is considered to be an improper technique when performing the inratio test.There was no reported adverse patient sequela and no additional information was provided.(note: this mdr filing is due to the device being the same or similar as a device available in the united states.).

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the in-house testing history for 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.The customer reported an unexpected high inratio inr result of >7.5.An inr result greater than the inratio's measurable range will result in an inr value of >7.5.Although the root cause analysis did not include return testing, an improper technique was identified in the complaint.This could not be ruled out as a cause of the unexpected result.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

Correction: the laboratory inr result was 2.8 not 2.9 as reported on the initial mdr.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL TEST STRIP
• 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: 5287233
• MDR Text Key: 33766624
• Report Number: 2027969-2015-01000
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/26/2015

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: Health Professional
• Device Model Number: 99008G1
• Device Lot Number: K373667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2016
• 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