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

Model Number 100139

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

Patient Problems Atrial Fibrillation (1729); Malaise (2359)

Event Date 09/02/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.On (b)(6) 2014, the inratio inr was 2.0.The therapeutic range was 2.0- 3.0.The following day, (b)(6) 2014, the patient was not feeling well and went to the hospital.At the hospital, the laboratory inr was 7.0.The patient was hospitalized for atrial fibrillation.Treatment included vitamin k and potassium.The patient was discharged from the hospital on (b)(6) 2014.Though requested additional information was not available to the physician's office who reported the complaint.

Manufacturer Narrative

Evaluation in progress.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 ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4135003
• MDR Text Key: 4913151
• Report Number: 2027969-2014-00866
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/05/2014

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: Health Professional
• Device Model Number: 100139
• Device Lot Number: 344282
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: No
• 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: INRATIO MONITOR SN (B)(4), COUMADIN, METOPROLOL
• Patient Outcome(s): Hospitalization; Required Intervention