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

Model Number 99008G2

Device Problem Low Test Results (2458)

Patient Problems Dehydration (1807); Hematuria (2558)

Event Date 04/02/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inr result in comparison to the laboratory inr result.On (b)(6) 2014, the patient's inratio inr was 2.7.The patient's therapeutic range was 2.0 - 3.0.On (b)(6) 2014, the patient was seen in the emergency room for hematuria, which had began on (b)(6) 2014.The laboratory inr was 10.9 and the patient was administered vitamin k 5mg orally.Forty-five (45) minutes later, the inratio inr result was 2.5 and the laboratory inr was 8.88.Reportedly, the first drop of blood was not used when applying the sample to the inratio test strip.The patient was then sent home.On (b)(6) 2014, the patient was dehydrated and seen in the emergency room.On (b)(6) 2014, the patient's laboratory inr was 1.3 as he been off coumadin and customer thinks he was started on lovenox.Patient was reported to be "feeling better".No add'l info was provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO PT/INR TEST STRIP
• 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: 3763298
• MDR Text Key: 4549592
• Report Number: 2027969-2014-00324
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110212
• 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: 04/02/2014

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: 99008G2
• Device Lot Number: 331340
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/10/2014
• 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: LOSARTAN 50MG DAILY; PROPRANOLOL 60MG DAILY; LOVENOX; INRATIO METER, SN (B)(4); OMEPRAZOLE 20MG DAILY; TRIAMTERENE/HCTZ 37.5/25MG DAILY; COUMADIN 8MG DAILY
• Patient Outcome(s): Required Intervention