MAUDE Adverse Event Report: ALERE SAN DIEGO INRATIO TEST KITS 12; INRATIO PRO TIME TEST

Model Number 100071

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This mdr is a retrospective filing that was identified during an internal assessment as part of capa (b)(4) related to unmonitored communications channels (e-mails, voicemails).Investigation results: it is indicated that the product is not returning for evaluation.A lot number of the test strip product was not provided and neither manufacturing record review nor testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.Alere has withdrawn the alere inratio®/inratio®2 pt/inr system from the market and is no longer manufacturing inratio® test strips and monitors.In addition, all alere inratio®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 alternate monitoring method, such as a plasma-based laboratory inr method or a point-of-care monitoring system from a different manufacturer.

Event Description

It was reported by a customer that after 8 years the inratio is not accurate.An inr result of 2.2 was obtained then in a sudden hospital visit, the inr result was 1.8.Then the inratio of 3.0 was measured compared to the lab at 2.58.No other information was received.

Manufacturer Narrative

Correction: common device name information from gis to gjs.

• Brand Name: INRATIO TEST KITS 12
• Type of Device: INRATIO PRO TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9093019
• MDR Text Key: 161364257
• Report Number: 2027969-2019-00432
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2354,2362-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization