MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Misdiagnosis (2159); Confusion/ Disorientation (2553)

Event Date 07/28/2015

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Patient self tester called alleging discrepant inratio values.Patient's therapeutic range 2-3.(b)(6) 2015: inratio = 2.2.(b)(6) 2015: patient self tester went to (b)(6) emergency room (er) due to cough, runny nose, and the loss of appetite lasting a week.Patient was treated with a rocephin injection, prescribed an oral antibiotic and was discharged on (b)(6) 2015.(b)(6) 2015: the patient was taken to (b)(6) emergency room by her husband because she felt dazed and confused.Lab inr was 12.0.Patient was treated with vitamin k via an intravenous drip.The hospital doctors informed her she might have had an allergic reaction to the antibiotics that caused her symptoms.Patient underwent a magnetic resonance imaging, to rule out a stroke, and her arteries were checked which showed "nothing" according to the patient.No diagnoses provided by the patient.(b)(6) 2015: patient signed herself out of the hospital prior to speaking with the doctor that day.All medications were stopped with the exception of her coumadin and a cholesterol medication.No other inr readings were provided by the patient that were performed at the hospital.Patient retested on the inratio at home and obtained a 1.3.(b)(6) 2015: inratio = 2.3.No additional information provided.

Manufacturer Narrative

Investigation conclusion: the meter that was originally listed as a concomitant device was returned for investigation.The strips were not returned.The customer's complaint was not confirmed during in-house testing.Retain strips tested on the returned meter met accuracy criteria.In addition, a review of the entire in-house testing history for the lot was performed.In-house strip testing on the reported strip lot meets release criteria.The product performed as expected.Manufacturing batch record review revealed no non-conformances.The lot meets release specifications.The returned meter passed functional and thermistor testing requirements during in-house investigation.The returned meter performed as expected.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.

Manufacturer Narrative

New information: the meter associated with the complaint was returned for investigation.The customer's complaint was not confirmed during in-house testing.Retain strips tested on the returned meter meet accuracy criteria.The meter met functional and thermistor testing requirements.The system performed as expected.A review of the entire in-house testing history for the lot was performed.In-house strip testing on the reported strip lot meets release criteria.Manufacturing batch record review revealed no non-conformances.The lot met release specifications.The customer's reported results were successfully located in the returned meter's memory; however, the customer's inr result of 1.3 was not located on the reported date of occurrence but appeared on (b)(6) 2015.Impedance curve analysis could not be performed on the customer's reported inratio inr results because only the last 4 impedance curves can be retrieved from the meter memory.The customer's results were not found within the last 4 impedance curves.Root cause could not be determined from the information provided by the customer.Capa-(b)(4) was initiated to investigate the cause of highly discrepant results.Further investigation into this issue is being performed under capa-(b)(4).

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• 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: 5058390
• MDR Text Key: 25106868
• Report Number: 2027969-2015-00651
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200432
• 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
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention