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

Model Number 100071

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); Nausea (1970); Pain (1994); Test Result (2695)

Event Date 12/28/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is pending.

Event Description

The husband of an end user called to report an alleged variance between the inratio inr results and the laboratory inr results.On (b)(6) 2015 at 10:30 am, the end user tested on the inratio device and received an inr result of 3.4.The therapeutic range was 2.0 - 3.0.The end user's normal warfarin dose of 10mg per day was reported to be taken.On (b)(6) 2015, the end user presented to the emergency room with leg pain.The laboratory inr was 9.1 at 4:00 pm.The end user was instructed to hold her warfarin until (b)(6) 2016.Zofran was administered for nausea and the end user was sent home.On (b)(6) 2015, the inratio inr was 3.1 and three (3) hours later at her physician's visit, the laboratory inr was 5.1.Warfarin had not been taken since (b)(6) 2015.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: the monitor associated with the complaint was returned for investigation; however, no testing strips were returned.The returned monitor memory was reviewed.The customer's inratio inr result of 3.1 on (b)(6) 2015 was identified in the monitor memory.The inratio inr result of 3.4 reported on (b)(6) 2015 was identified in the monitor memory as occurring on (b)(6) 2015.Impedance curve analysis could not be performed on the customer's reported inratio inr result of 3.4 since only the last impedance curve can be retrieved from the inratio 1 monitor memory.A statistical analysis of an impedance curve generated when the customer's inratio monitor produced the result of 3.1 on (b)(6) 2015 determined that the curve exhibited a normal slope change.The returned monitor met functional and thermistor testing requirements during the investigation.The returned monitor performed as expected.Retained strips of the reported lot 370763ar and four (4) strips of lot 370763a were used to complete the investigation as the reported lot was depleted during the strip investigation.Strip lot 370763a was used for the investigation as it was identical to the materials used in the reported lot.The customer's complaint was not confirmed during in-house testing.Retained strips tested on the returned monitor met accuracy criteria.A review of the in-house testing history for strip lot 370763ar was conducted.In-house testing on the reported strip lot meets release criteria.The manufacturing records for the lot were reviewed and the lot met release specifications.Internal capa-(b)(4) was initiated to investigate highly discrepant results.

• 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 (Section G): 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: 5379792
• MDR Text Key: 36417851
• Report Number: 2027969-2016-00039
• 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: distributor,other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

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: 370763AR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2015
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention