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 Anemia (1706); Bacterial Infection (1735); Cardiac Arrest (1762); Death (1802); Cardiac Enzyme Elevation (1838); Hemorrhage/Bleeding (1888); Urinary Tract Infection (2120); Weakness (2145); Chills (2191); Loss of consciousness (2418); Confusion/ Disorientation (2553); Hematuria (2558); Test Result (2695)

Event Date 02/21/2014

Event Type  Death  

Event Description

Customer reported, via telephone call, that on (b)(6) 2014 at 11:00, a (b)(6) old male, (b)(6) patient experienced chills, three (3) dark tarry stools and urine was noted to be cloudy with sediment.The inratio inr was 3.9 and prothrombin time (pt) was 38.9.The patient's therapeutic range is 2.0-3.0.At 22:06, the patient experienced bright red blood in stool.On (b)(6) 2014, the patient was becoming weaker and a little more incoherent.He was hospitalized at 10:42 with rectal bleeding and unresponsiveness.Laboratory inr was 8.08, hemaglobin (hgb) 7.6 and hematocrit (hct) 24.7.Treatment over course of hospitalization included transfusion of 6 units fresh frozen plasma (ffp), 4 units packed red blood cells (prbc), protonix drip, antibiotics, monitoring of hgb/hct and internal medicine consultation.The inr at 21:10 was 2.31, hgb 8.2 and hct 25.8.The patient's blood counts continued to improve.No further inr was performed.On (b)(6) 2014 at 00:05 patient's status declined and code was called.The patient was intubated and troponin at 00:20 was 7.147.The urine showed escherichia coli (e.Coli).The patient expired on (b)(6) 2014 at 05:30.No additional information was provided.

• 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 king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3700785
• MDR Text Key: 4234021
• Report Number: 2027969-2014-00210
• 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: Other
• Type of Report: Initial
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• 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: 333655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2014
• 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 5MG DAILY; DULCOLAX SUPPOSITORY 10MG AS NEEDED; OMEPRAZOLE 20MG DAILY, STARTED; CEPHALEXIN 250MG TWICE DAILY, STARTED; KEPPRA 500MG TWICE DAILY; LOMOTIL 2 TABLETS AS NEEDED AFTER EACH LOOSE STOOL; EVERY FOUR HOURS AS NEEDED; HALDOL 1MG AS NEEDED; BUMEX 1MG TWICE DAILY; SENNA S, NIGHTLY; HYDROMORPHONE 4MG (5 TABLETS OR 20MG)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 83