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

Model Number 100071

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

"caller alleged discrepant results compared with the lab.Results as follows:" date: (b)(6) 2014, inratio: 1.6, lab: 3.4.Tests conducted within an hour of each other.Therapeutic range: 2.0-3.0.The strips that were used are past their expiration date.Meter was not in correct mode when fingerstick was performed; pt self tester was milking finger after fingerstick.

Manufacturer Narrative

The customer reported a discrepant low inratio inr result during testing.It is indicated that product is not returning for evaluation.Therefore, investigation of the complaint to determine root cause cannot be completed.Since the product associated with the complaint was not returned, a review of in-house retain testing ws performed.Retain strip testing results met both accuracy and repeatability criteria.The products performed as expected and no product deficiencies were observed.The customer utilized expired inratio strips during testing.The use of expired products may have contributed to the unexpected inratio inr result.Additionally, improper use of the meter and improper techniques were identified in the complaint.This cannot be ruled out as a possible root cause for the unexpected results.The manufacturing records for the lot were reviewed.The lot met specifications an non-conformances were documented.Further investigation will not be pursued at this time.Based on the info available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: INRATIO
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3851841
• MDR Text Key: 4656237
• Report Number: 2027969-2014-00330
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• 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: 303229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2014
• 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