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); High Test Results (2457)

Patient Problems No Consequences Or Impact To Patient (2199); Test Result (2695)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

A variance was reported between inratio inr results and lab inr result.The results were as follows: (b)(6) 2016: inratio=6.3, lab=1.2, inratio=1.2; unknown therapeutic range.On (b)(6), nurse took inr on inratio monitor and received a 6.3.Immediately after, took venous draw from the patient's arm and went to the lab and received a 1.2 from lab.Came home to retest on monitor and received a 1.2 on inratio monitor.It was also reported that the patient is on unspecified antibiotics; no dosage provdied.

Manufacturer Narrative

The product was not returned for evaluation.Therefore, a review of the entire testing history for the reported lot was performed.In-house testing on strip lot 370105ar 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.A root cause could not be determined from the available information.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 rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5696212
• MDR Text Key: 47309216
• Report Number: 2027969-2016-00418
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 100071
• Device Lot Number: 370105AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• 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