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); Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

Caller reported variance between inratio inr results and lab inr result.The results were as follows: (b)(6) lab inr = 1.5.(b)(6): inratio = 2.5.(b)(6): inratio = 4.4 then 4.3.Also experienced nes errors (not enough sample) while testing.The reported therapeutic range was: 3.0-3.5.Lovenox was administered prior to (b)(6) and last dose was on (b)(6).Patient's husband chose not to administer a dose on (b)(6) because the inratio inr was 4.4 and 4.3.Warfarin was resumed on (b)(6) after the patient's scheduled procedure.

Manufacturer Narrative

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 testing on the reported strip lot met release criteria.The product performed as expected.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.The manufacturing records for the lot were reviewed; the lot met release specifications.The reported off-label usage could not be ruled out as a cause of the error experienced by the customer.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: 5757238
• MDR Text Key: 49255649
• Report Number: 2027969-2016-00475
• 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: 06/01/2016

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: 385940A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• 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