MAUDE Adverse Event Report: ALERE SAN DIEGO, INC INRATIO/INRATIO2 TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

Caller alleged discrepant inratio inr results.On (b)(6) 2014, the pt received an inratio error code 750.There is no such error code and it was concluded that it was likely a result of >7.5.The batteries were replaced on the meter and the inratio result was 2.6.The pt's therapeutic range was 2.0 - 3.0.On (b)(6) 2014, the pt's was seen at the their physician's office with unspecified bruising and bleeding.The warfarin was stopped and laboratory inr was drawn.On (b)(6) 2013 the laboratory inr result, that was drawn on (b)(6) 2014, was received.The inr was 11.4 and the pt was sent to the emergency room where they were hospitalized, warfarin was stopped and the pt was administered vitamin k and plasma.The pt had since been discharged.There was no add'l info provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO/INRATIO2 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: 3888087
• MDR Text Key: 4424368
• Report Number: 2027969-2014-00339
• 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: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• 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: 308060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• 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: WARFARIN STOPPED ON; INRATIO METER SN (B)(4)