MAUDE Adverse Event Report: ALERE SAN DIEGO, INC INRATIO2; PROTHROMBIN TIME TEST

Model Number 100071

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hematuria (2558)

Event Date 01/13/2014

Event Type  Injury  

Event Description

Caller discrepant inratio2 results.Results as follows: date: (b)(6), inratio2: 2.3, lab: 9.0.Date: (b)(6), inratio2: 2.4, nurse's poc: 4.4.Time between tests: (b)(6) exact time unk.Caller stated it was in the same day, <12 hours apart.On (b)(6) nurses poc reading was obtained at 10am; inratio result at 2pm.Therapeutic range 2.5-3.5.On (b)(6) the pt self testers physician increased the coumadin dose based on the inratio results.Later the same day, the pt was taken to the hospital due to blood in the urine.Coumadin dose withheld.Caller reports milking finger after finger stick and not applying the sample immediately after the finger stick.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO2
• 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: 3701042
• MDR Text Key: 4249805
• Report Number: 2027969-2014-00214
• 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: 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: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 333863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/11/2014
• 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: ASPIRIN 81MG DAILY; COUMADIN 5MG; CIPRO; CLONAZEPAM
• Patient Outcome(s): Hospitalization