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 Problems Bruise/Contusion (1754); Test Result (2695)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio values.Patient's therapeutic range = 3.5 - 4.5.On (b)(6) 2016 inratio inr = 7.5.On (b)(6) 2016 inratio inr = 7.5 due to patient's high results, she was taken off coumadin.Her usual dose of coumadin is 3.5mg/day.On (b)(6) 2016 inratio inr = >7.5.On (b)(6) 2016 hospital lab inr = 20.43 (time unknown).On (b)(6) 2016 in response to the last high inratio result from (b)(6) 2016 of >7.5, patient self tester was admitted to (b)(6) hospital.A venous blood draw lab test was performed and resulted in inr = 20.43.Exact time of lab test was not specified by patient.Patient's physician also administered a one-time, unspecified antibiotic - dose unknown.Patient was treated with plasma infusions and as of (b)(6) 2016 was currently still in the hospital and had not been discharged.Patient stated that her body was covered in bruises and that she had over 25 bruise spots on her "arms and legs alone." the inratio product has a maximum reporting range of >7.5.This adverse event is being conservatively filed.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the reported lot was performed.In-house strip testing on the reported strip lot meets accuracy criteria.The product performed as expected and no product deficiency was identified.Although a relevant nc was noted in batch record, it did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.The customer did not provide a lab comparative for the reported inratio results of 7.5 from (b)(6).It is not possible to verify if a discrepancy exists without this information.The customer reported an unexpected high inratio inr result of >7.5 on (b)(6) 2016.An inr result greater than the measurable range will result in an inr value of >7.5.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: 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: 5780580
• MDR Text Key: 49129206
• Report Number: 2027969-2016-00502
• 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: Initial,Followup
• Report Date: 06/10/2016

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: 387627A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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