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

Model Number 100071

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide a lot number or return any products for investigation.Since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.Trend code analysis is performed monthly.

Event Description

The caller alleged a variance between the inratio inr result in comparison to the lab inr result.The results were as follows: (b)(6): inratio= 3.4, (b)(6): lab= 5.9.The patient self tester's therapeutic range is: 2.5-3.5.The patient self tester had sporadic nose bleeds on the morning of (b)(6) (bleeding on and off).They also noticed some localized bruising on the arm.Patient self tester decided to check inr using inratio and had an inratio inr=5.0 (using a different lot of strips).Patient self tester immediately called physician and went to the lab for a test.Lab inr result=5.9.Physician advised the patient to hold coumadin until inr returns to therapeutic range.Nose bleeds stopped on their own; no treatment administered for nose bleeds or localized bruising.No treatment was administered; no vitamin k prescribed.

• 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: 5062308
• MDR Text Key: 25892074
• Report Number: 2027969-2015-00656
• 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: Patient
• Type of Report: Initial
• Report Date: 08/13/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2015
• Initial Date FDA Received: 09/08/2015
• 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