MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problem High Test Results (2457)

Patient Problems Headache (1880); Inflammation (1932); Brain Injury (2219)

Event Date 12/28/2014

Event Type  malfunction  

Event Description

Caller reporting discrepant high inratio values (b)(6) 2014, inratio 6.2, lab 3.2, tests performed within three hours.(b)(6) 2015, inratio 5.7.(b)(6) 2015, lab 3.2, one day between tests performed on (b)(6) 2015.Patient's therapeutic range 2.5 - 3.5.No coumadin dosage changes between receiving the inratio result and the corresponding lab result.Patient self tester went to the er on (b)(6) 2015 after experiencing severe headaches on (b)(6) 2015.Inr (venous draw) was taken upon admittance.Patient admitted and diagnosed with brain inflammation.Patient hospitalized for one week during which the patient was taken off coumadin and placed on lovenox.Patient underwent brain surgery for the inflammation during hospitalization, no exact date available.Patient was released to home 1 week after admittance, patient currently comfortable at home.Requested discharge diagnosis.Per patient, no discharge diagnosis available.Patient stated that physician had stated the inflammation was consistent with severe trauma to the head (a contusion), however patient states that no trauma was experienced prior to hospitalization.Patient currently taking lovenox but will be bridged back to coumadin shortly.No additional information available.

Manufacturer Narrative

Investigation conclusion: it is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.Retain strip testing results met both accuracy and repeatability criteria.The products performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed.The non-conformance associated with this lot was not relevant to the initial complaint and does not affect product performance.Root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• Brand Name: INRATIO PT/INR STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4504615
• MDR Text Key: 20374067
• Report Number: 2027969-2015-00097
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 354045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/10/2015
• 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: COUMADIN TAKEN OFF (B)(6) WILL BE BRIDGED BACK; LOVENOX; INRATIO MONITOR SERIAL #(B)(4)