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

Model Number 100071

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Patient self tester's wife called alleging discrepant inratio results.(b)(6) 2015: inratio = 2.5.(b)(6) 2015 patient went to the emergency room due to feeling ill.Diagnosis was acute kidney failure.Patient was given fluids and potassium.No other medication given other than usual daily medication, list of medications not provided.Hospital lab = 9.0.No other treatment or medication provided.(b)(6) 2015: lab = 8.0.(b)(6) 2015: inratio = 2.5; lab = 3.4 time between tests not provided.08/11/2015 lab = 2.8; inratio = 3.4 time between tests not provided.Patient discharged on (b)(6) 2015.No other treatment or medication given during hospital stay.Patient's therapeutic range 2 - 4.No other information provided.

Manufacturer Narrative

Investigation conclusion: the meter associated with the complaint was returned for investigation.Retained strips of the reported lot were tested because the customer's strips were not returned.The customer's complaint was not confirmed during in-house testing.Retained strips tested on the returned meter met accuracy criteria.The returned meter met functional and thermistor testing requirements during the investigation.The returned meter performed as expected.A review of the entire in-house testing history for strip lot 367839a was conducted.In-house testing on the reported strip lot meets release criteria.Manufacturing batch record review revealed no non-conformances.The lot meets release specifications.It was reported that the patient had acute kidney failure.This condition may impact the performance of the assay.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 TEST 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: 5051692
• MDR Text Key: 24894237
• Report Number: 2027969-2015-00645
• 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,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/11/2015

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: 367839A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention