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 Coagulation Disorder (1779); Nausea (1970); Pain (1994); Thrombus (2101); Vomiting (2144); Hematuria (2558); No Code Available (3191)

Event Date 02/10/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.On (b)(6) 2014, the patient's inratio inr result, in the primary care physician's office, was 2.0.Reportedly, the meter was not in the correct mode when finger stick was performed.The sample was not applied immediately after the finger stick and first drop of blood was not used.Additionally, improper capillary tube was used.The patient's target range is 2.0-3.0.Within one hour (12:14), the patient's laboratory inr result was 8.0.The (b)(6) , female patient presented with suprapubic and low back pain to the emergency room the same day.The pain was described as progressive in nature, stabbing in quality resulting in progression of nausea and vomiting.The patient is with a one day history of hematuria.Original computerized tomography (ct) scan, ordered by physician prior to onset of pain, showed no acute abnormality.The follow-up abdomen and pelvis ct scan in the emergency room revealed a very mild left hydronephrosis and some perirenal fluid consistent with possible fornical rupture.There was filling defects in the renal pelvis and ureter consistent with clots.The patient was admitted to the hospital and given pain medication, antiemetic, intravenous (iv) hydration and urology consultation ordered.The second laboratory inr (22:05) was 8.4.On (b)(6) 2014 (04:23), the laboratory inr was 6.9.Urology consultation was performed and correction of coagulopathy with 2 unites of fresh frozen plasma (ffp) given.Per urologist, the urethral clots would absorb spontaneously over time.Urologist offered to place ureteral stent; however, patient deferred.At 18:38 the inr was 3.3 and on (b)(6) 2014 (04:27) inr was 3.4.No discharge was provided.There was no additional information 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: 3687465
• MDR Text Key: 4297568
• Report Number: 2027969-2014-00195
• 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: 02/12/2014

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: 330238
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/07/2014
• 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 2 PT/INR PRO MONITOR SN 123738087; SYNTHROID 50MCG DAILY; LAST DOSE TAKEN; COUMADIN 4MG M/T/TH/F/SAT; AMOXICILLIN 50MG THREE TIMES DAILY; COUMADIN 6MG SUN/WED; VITAMIN D3 4000 UNITS DAILY; FLECAINIDE 10 MG TWICE DAILY; ATIVAN 0.5MG THREE TIMES DAILY AS NEEDED; ZOLOFT 100MG DAILY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR