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

Model Number 100139

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Issue (2379)

Patient Problems Hemorrhage/Bleeding (1888); Misdiagnosis (2159); Test Result (2695)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio values.Patient's therapeutic range 2-3.On (b)(6) 2016 inratio inr = 2.2.On (b)(6) 2016 lab inr = 16.On (b)(6) 2016 patient was admitted to (b)(6) medical center for bleeding from a pre-existing diabetic wound that was being treated; laboratory inr conducted upon admittance, lab inr=16.Following laboratory inr, coumadin was held for 3 days.Patient was also administered vitamin k and fluids for three days.Patient was not given any other medications/treatments.On (b)(6) 2016 patient was discharged from hospital with a lab inr = 6.5.Caller provided diagnosis as bleeding and critical inr.On (b)(6) 2016 inratio inr = 2.4.On (b)(6) 2016 inratio inr = 4.2 and lab inr = 4.9 (testing occurred simultaneously).Coumadin dose prior to (b)(6): 5 mg x3/week, 2.5 mg x4/week.Coumadin dose after (b)(6): 2.5 mg/day.

Manufacturer Narrative

Investigation/conclusion: the meter and strips associated with the complaint were returned for investigation.Returned strips tested on the returned meter met accuracy criteria.The customer's complaint was not replicated during in-house testing.Additionally, the returned meter met functional and thermistor testing requirements during investigation.A review of the manufacturing batch records for the reported strip lot did not uncover any non-conformances.The lot met release specifications.The customer was identified as having a condition that may impact the performance of the assay.This can not be ruled out as a cause for the observed discrepant results.Impedance curve analysis was not performed because the customers reported inr results were not present in the meter memory.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: 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: 5677153
• MDR Text Key: 45857469
• Report Number: 2027969-2016-00399
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100139
• Device Lot Number: 384911A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention