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

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Congestive Heart Failure (1783); Overdose (1988); Renal Failure (2041); Pallor (2468); Patient Problem/Medical Problem (2688)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Patient self tester's daughter called alleging discrepant low inratio value.On (b)(6) 2015 patient self tester tested on inratio and obtained an inr of 2.8.This inr value was reported to her physician.(b)(6) 2015 the patient's daughter noticed that her mother was looking pale and did not look right so the patient self tester was taken to the (b)(6) hospital via ambulance.Patient's daughter mentioned that the patient has been hospitalized 8 times for trans ischemic attacks since november 2014 and had only been home for a total of 6 weeks since her last hospitalization.(b)(6) 2015 the initial lab inr at the hospital was 12.0.The patient was given blood transfusions (number of transfusions not provided) and 2 vitamin k injections.Recheck via the hospital lab resulted in an inr of 1.1 on (b)(6) 2015.Per the patient's daughter, the patient was diagnosed with acute renal failure and "coumadin sepsis".Upon clarification, daughter stated nurse used the term "sepsis".Patient was hospitalized in the intensive care unit.The patient was moved from the intensive care unit to another floor on her 3rd or 4th day at the hospital.Patient was given more blood transfusions, which caused congestive heart failure and fluid to build up in her body and lungs.Patient was then transferred to cardiology floor for monitoring.Patient is currently on intravenous lasix for the fluid build up.Patient's daughter stated that the patient has had a history of chronic urinary tract infections (uti) and was diagnosed with the beginning of a uti along with sepsis upon being admitted.No further inr results (from the inratio or lab) provided by the customer.Patient's therapeutic range 2.5 - 3.5.

Manufacturer Narrative

Investigation conclusion update: it is indicated that the product is not returning for evaluation.Therefore, a review of in-house testing was performed.In-house testing on strip lot 357499 meets release criteria.The product performed as expected.Although a relevant nc was noted in the 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.It was reported that the customer was diagnosed with acute renal failure and "coumadin sepsis." sepsis and renal failure may impact the performance of the assay.Root cause cannot be determined from the information provided.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: 5024972
• MDR Text Key: 23860312
• Report Number: 2027969-2015-00614
• 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 Health Care Professional
• Type of Report: Followup
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• 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: 357499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention