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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

Conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire testing history for the reported lot was performed.In-house testing on strip lot 384085a meets release criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any relevant non-conformances.The lot met release specifications.Technique and user issues were identified in the complaint which may have contributed to the unexpected results observed by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

Caller reported discrepant inratio results.Results as follows: date: 4/20/2016, inratio:1.1, re-test: 2.0.Time between tests: 5 minutes.The following historical inratio value was provided: date: 4/13/2016, inratio: 2.1.Therapeutic range: 2.0-3.0.The patient self tester stated he was milking the finger during the re-test and not applying the blood within 15 seconds of sticking the finger on the first test.No report of death or serious injury.

• 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 ; 8588052048
• MDR Report Key: 5665154
• MDR Text Key: 45477384
• Report Number: 2027969-2016-00324
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• 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: 384085A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• 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