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

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problem Hematuria (2558)

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.Alere has withdrawn the alere inratio®/inratio®2 pt/inr system from the market and is no longer manufacturing alere inratio® test strips and monitors.In addition, all alere inratio® test strips are now expired.Customers have been advised to work with their healthcare provider to transition to an alternative monitoring method, such as a plasma-based laboratory inr method or a point-of-care monitoring system from a different manufacturer.

Event Description

Discrepant low inr result 1x on 1 meter/1 lot.Unspecified date: inratio=~3.8 (therapeutic range: 2-3).Coumadin dose was adjusted based on the high reading (did not specify what the adjustment was).After obtaining this result, the pst went to hospital within 24 hours where she had blood in her urine.Lab inr=5.3.States no treatment (e.G.Vitamin k, ffp) was administered.Blood in urine persisted for 48 hours.Physician advised pst to drink lots of water.Urine was tested 6x over the 48 hour period.Several other unspecified tests were also performed; pst unable to provide further information.No further information provided.

• 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 Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 8286122
• MDR Text Key: 136749286
• Report Number: 2027969-2019-00011
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Model Number: 100071
• Device Lot Number: 370763A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2354, 2362-2016
• Patient Sequence Number: 1