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); Unspecified Infection (1930)

Event Date 08/04/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the lab inr result.Results are as follows: date: (b)(6) 2014, inratio inr: 5.9 (0700), lab inr: na; (b)(6) 2014, 4.4 (1615), 9.0 (1000).Therapeutic range: 3.0 4.0.Reportedly, the pt reported unspecified bleeding and that she was bruised almost everywhere on her body except for her face.The was seen in the emergency room for a bladder infection.At that time, lab inr was drawn and was 9.0.The pt's coumadin was held from (b)(6) 2014 - (b)(6) 2014.There was no add'l info provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4060304
• MDR Text Key: 4909509
• Report Number: 2027969-2014-00778
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 341191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 08/25/2014
• 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
• Treatment: UNSPECIFIED HEART MEDICATION; COUMADIN 5MG AND 7MG ALTERNATING; INRATIO MONITOR: SN (B)(4)
• Patient Outcome(s): Required Intervention