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 Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

Event Date 08/28/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: retain strip investigation was not performed on the returned meter.The recovered impedance curve associated with the customer's reported inratio inr result exhibited a weak-slope change.Weak slope changes are known to contribute to discrepant results.This issue is related to the algorithm software on the meter and was addressed in capa-(b)(4).Due to this root cause being identified as the cause of the customer's discrepant results, donor testing of the meter was not necessary.The returned meter met functional and thermistor testing.A review of the entire in-house testing history for the reported strip lot was conducted.In-house testing on the reported strip lot meets accuracy criteria.The manufacturing records for the lot were reviewed and the lot met release specifications.The customer was reported to have upper gastrointestinal bleeding and stomach flu; these conditions may impact the performance of the assay.Capa-(b)(4) identified impedance curves with weak slopes as potentially leading to discrepant inr values.Further investigation is being performed under capa-(b)(4) for this issue.

Event Description

Report received of discrepant inratio value.Patient's therapeutic range 3.5 - 4.5.On (b)(6) 2016 during the evening, the patient self tester tested his inr using the inratio monitoring system and received an inr of 3.8.On (b)(6) 2016 in the early morning, the patient was feeling very ill (specifics not provided) and went to the emergency room where his inr was tested at 7:39am using venous blood and his inr was 6.8 and hemoglobin was very low (value not available).The patient was admitted with and upper gi bleed and endoscopy identified a mallory-weiss tear and used a stainless steel clamp to seal the tear.In order to perform the procedure, the patient was given vitamin k and a heparin drip simultaneously and also jumbo plasma and blood transfusions for the blood loss.On (b)(6) 2016 patient was released in the evening with an inr of 1.3 and hemoglobin of 7.9 - patient stated that it was purposely high in order to limit the amount of blood transfusions.On (b)(6) 2016 cbc showed hct at 27.8 and red blood count at 2.89.On (b)(6) 2016 inr = 2.9 via laboratory venous draw, patient instructed to take 12mg of coumadin.On (b)(6) 2016 patient administered lovenox in the morning and had his inr evaluated via laboratory venous method which reported an inr of 4.7.No additional information provided.

• 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: 6001592
• MDR Text Key: 56538862
• Report Number: 2027969-2016-00640
• 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: Initial
• Report Date: 09/08/2016

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: 200432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 10/05/2016
• 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: Z-0880,0881,0882-2015
• Patient Sequence Number: 1
• Treatment: INRATIO PT/INR TEST STRIPS 100071 LOT #388422A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68