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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Hematuria (2558)

Event Date 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

The caller (wife of patient self tester) alleged a variance between inratio inr results.The results reported as follows: (b)(6) 2015: inratio=1.4.(b)(6) 2015: inratio=1.9.(b)(6) 2015: inratio=3.0.The patient self tester's therapeutic range: 2-3.Patient self tester's warfarin dose was increased on (b)(6) 2015 due to result of 1.4; 7.5mg that night and 5mg for the remaining week.Wife also stated that her husband has noticed some blood in the urine over the past week.No lab tests performed and patient self tester did not consult his physician - wife is a nurse.Wife was not concerned about the hematuria, she just stated that they noticed some blood in the urine.Patient self tester/wife will continue to monitor and see if the bleeding will go away with his dosage change.

Manufacturer Narrative

The customer did not provide any reference values for comparison.The accuracy of the customer's inratio results cannot be determined without this information.It is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.Retain strip testing results met both accuracy and strip repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot did not uncover any relevant non-conformances.The lot meets release specification.Root cause is unable to be determined from the information provided.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: 4955156
• MDR Text Key: 24651547
• Report Number: 2027969-2015-00553
• 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
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• 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: 355822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• 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