MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR PROFESSIONAL TEST STRIP; PROTHROMBIN TIME TEST

Model Number 99008G2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Angina (1710); Nausea (1970); Urinary Tract Infection (2120); Vomiting (2144)

Event Date 04/15/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio2 inr result in comparison to the lab inr result.On (b)(6) 2014, the inratio2 inr was 4.1 and coumadin was held.This was the first test performed on the pt since admission to home health on (b)(6) 2014.The first drop of blood was not used and the sample was not immediately applied.In addition, a capillary tube was used to apply the sample.The pt's therapeutic range was 2.0 - 3.0.On (b)(6) 2014, the pt presented to the emergency room with complaints of sharp, left-sided chest pain with two (2) episodes of vomiting.The pt had chest pain with nausea two (2) nights prior but did not f/u and eventually the symptoms subsided.In the emergency room the pt was treated with unspecified medication and the chest pain resolved.Lab tests in the emergency room showed severe anemia with a hemaglobin (hgb) = 6.3 and hematocrit (hct)=20.7.In addition, the inr was not calculated, prothrombin time (pt) was greater than 120, elevated troponin and abnormal urinalysis.Chest x-ray showed early infiltrate in the right mid lung and small infiltrate in the right base versus subsegmental atelectasis.Treatment included admission to icu, intravenous (iv) antibiotics for urinary tract infection and possible pneumonitis, transfusions of six (6) units of packed red blood cells and holding of all anticoagulants.Critical care, cardiology, renal and gastrointestinal (gi) evals were requested.Per nurse at home care facility and facility notes, the pt was hospitalized due to shortness of breath, chest pain, elevated inr due to warfarin use, internal bleed of unk origin.In addition, there was no surgical intervention related to the reported internal bleed of unk origin.On (b)(6) 2014, the pt was discharged home in stable condition.Though requested, there was no add'l info provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL 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: 3839047
• MDR Text Key: 4413899
• Report Number: 2027969-2014-00437
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/24/2014

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: 335553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1564-2014
• Patient Sequence Number: 1
• Treatment: METOPROLOL 25 MG DAILY; CRESTOR 20 MG DAILY; INTRATIO MONITOR: SN (B)(4); NORCO 5/325 1 TABLET EVERY 6 HOURS AS NEEDED; PLAVIX 75 MG DAILY; XANAX 0.5 MG AT BED; CARVEVILOL 3.125 MG TWICE A DAY; VITAMIN D 400 UNITS DAILY; ISOSORBIDE DINITRATE 10 MG DAILY; AMIODARONE 200 MG DAILY; WAS ON (B)(6) 2014; ASPIRIN 81 MG; CLINDAMYCIN 150 MG, (B)(6) 2014; COUMADIN STARTED (B)(6) 2014, LAST DOSE WAS 6 MG; LASIX 40 MG DAILY; LANTUS INSULIN 6 UNITS IN AM AND 6 UNITS IN PM; MIRTAZAPINE 15 MG AT BED
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 84