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 Occlusion (1984); Hematuria (2558)

Event Date 04/07/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio2 inr result in comparison to the laboratory inr result.On (b)(6) 2014, a (b)(6) male presented to his primary care physician's office for an evaluation for liver biopsy related to elevated liver function tests and a colonoscopy related to a new onset of rectal bleeding.The laboratory inr was performed in addition to normal blood work for checkup.Laboratory results at 14:35 are as follows: inr=14.2 and prothrombin time (pt)=161.9.The patient's therapeutic range was 2.0 - 3.0.Approximately 15:10, the inratio2 inr was performed at an anticoagulation "coumadin" clinic.The result was 2.3.Reportedly, the monitor was not in the correct mode when the finger stick was performed and the sample was not immediately applied to the sample well.In addition, a capillary tube was used to obtain sample.The patient was hospitalized after receiving the laboratory inr result.In the hospital, the laboratory results were as follows: (17:45) inr=15.9; pt=180.2 (19:45) inr=12.1; pt=137.2; partial thromboplastin time (ptt)=75; hemoglobin (hgb)=16.7; hematocrit (hct)=46.4.Urinalysis, performed on (b)(6) 2014, showed the urine to be red in color with a large amount of occult blood.The patient's coumadin was held and vitamin k 10mg was administered intravenously (iv).On (b)(6) 2014 at 06:38, laboratory results as follow: inr=2.0; pt=21.7; hgb=15.3 and hct=43.4 consultation notes, dated (b)(6) 2014, indicated that the patient was to have a colonoscopy performed prior to discharge on (b)(6) 2014 and liver biopsy to be performed on an outpatient basis.On (b)(6) 2014 at 07:39, laboratory results as follows: inr=1.3; pt=13.4; hgb=15.4; and hct=43.6.There was no additional information 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: 3872106
• MDR Text Key: 4594433
• Report Number: 2027969-2014-00349
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• 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: 226668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2014
• 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
• Patient Sequence Number: 1
• Treatment: METOPROLOL SUCCINATE XL: 100MG DAILY; ASPIRIN: 81MG DAILY; DILTIAZEM CD: 240MG DAILY; SPIRONOLACTONE: 25MG DAILY; NORCO: 5/325MG 1 TAB AS NEEDED; INRATIO MONITOR: SN (B)(4); AMBIEN: 5 MG BEDTIME AS NEEDED; BUMETANIDE: 1MG TWICE DAILY; COUMADIN: 3MG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR