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

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problem No Information (3190)

Event Date 05/01/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.On (b)(6) 2014, the laboratory inr was >15.The pt/s therapeutic range was 2.0 - 3.0.The physician requested that the pt test his inratio inr for comparison.The results were 3.8 and 3.1 (lot# 334579), four (4) hours after the laboratory inr.The pt was instructed to go to the emergency room where he was hospitalized on (b)(6) 2014, administered vitamin k and his coumadin was held.Through requested, there was no add'l info provided.

Manufacturer Narrative

The inratio pt/inr test strips lot 334577r is being reported under separate mfr report number 2027969-2014-00543.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: 3908145
• MDR Text Key: 4516932
• Report Number: 2027969-2014-00542
• 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: 05/07/2014

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: 334579
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 06/04/2014
• 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: PLAVIX; DIOVAN; DIGOXIN; INRATIO MONITOR (B)(4); INRATIO PT/INR TEST STRIPS LOT 334577R; VITAMIN D; TOPEROL; PRAVASTATIN; LASIX; LEVAQUIN; COUMADIN
• Patient Outcome(s): Hospitalization; Required Intervention