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

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Hematuria (2558); Cancer (3262)

Event Date 04/01/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.Pt tested on the inratio and received a 2.0 result.The patient's finger was touched to the sample well.The patient's blood appeared to be "pink" in color; therefore, he was taken to the emergency room.The laboratory inr was 25.0.The time between testing was four (4) hours.The pt was hospitalized for internal bleeding.After hospitalization, on (b)(6) 2014, the patient's inr reached 29.Reportedly, he was experiencing hematuria and "splitting up blood clots".Treatment included stopping coumadin, administration of vitamin k and plasma.After treatment, the patient's inr was down to 1.6 and bleeding had stopped without any surgical intervention.There was no further bleeding episodes.On (b)(6) 2014, the inr result was 2.3.During hospitalization, the pt was diagnosed with metastatic prostate cancer with multiple bone lesions.On (b)(6) 2014, the pt was discharged under comfort care and subsequently expired on (b)(6) 2014 from advanced metastatic cancer (unrelated to the inratio device).Though requested, there was no add'l info 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: 3804621
• MDR Text Key: 16799700
• Report Number: 2027969-2014-00382
• 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: 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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 332831
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/29/2014
• 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,; CIPRO AND AN ADD'L TWO (2) UNSPECIFIED ANTIBIOTICS
• Patient Outcome(s): Hospitalization; Required Intervention