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

Model Number 100071

Device Problems Nonstandard Device (1420); Low Test Results (2458)

Patient Problems Death (1802); Dyspnea (1816); Paralysis (1997); Transient Ischemic Attack (2109)

Event Date 07/22/2014

Event Type  Injury  

Event Description

On (b)(4) 2015, a phone call was received from the patient's husband after he received the alere inratio pt/inr monitor system urgent medical device correction notification, dated (b)(6) 2014.He reported that in (b)(4) 2014, the patient's inratio inr was between 2.0-3.0.The patient's therapeutic range was 2.0 - 3.0.There was no reported reference testing performed at that time.Approximately 9-15 days later, the patient was hospitalized with shallow breathing.The laboratory inr was 8.0 and vitamin k was administered.After several days of vitamin k treatment, the patient developed a clot and experienced a stroke with paralysis to one half of her body.The patient was discharged home under the care of her husband.The patient stopped using the inratio device, following hospitalization, as she was changed from coumadin to xarelto.In an attempt to obtain additional information, alere home monitoring, inc.(ahm) was contacted and was able to provide an inratio inr result of 2.8 on (b)(6) 2014; however no additional information was available.It was also discovered, through a (b)(6) search, that the patient expired on (b)(6) 2015.The cause of death is currently unknown.Several attempts have been made to obtain additional information from the physician's office; however no additional information was provided.The report filing is due to the discrepancy in the patient results and subsequent required medical intervention.At this time, there is no information to suggest that the device caused or contributed to the death which occurred approximately six (6) months after the reported event.

Manufacturer Narrative

Investigation/conclusion: though requested, the patient's spouse was unwilling to return the monitor.Since the products associated with the complaint were not returned, a review of in-house testing was performed.However at the time of the investigation, retains for the complaint lot# 334580 were no longer available.As a result lot# 334578 was used for internal investigation purposes.This lot contained identical raw materials.The retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.The manufacturing records for the lot were reviewed and there were no issues related to this complaint.The root cause could not be determined from the information provided by the customer.However, due to the time between the inratio test result and the laboratory reference result, obtained approximately 9-15 days later, coagulation may change significantly in this time frame.Changes in the patient's status may have contributed to the unexpected results.(b)(4) was opened to investigate potential discrepancies in which the device inr result is 4 or more inr units below the reference result.

• 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: 4483923
• MDR Text Key: 5498394
• Report Number: 2027969-2015-00070
• 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: Other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/06/2015

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 Expiration Date: 03/31/2015
• Device Model Number: 100071
• Device Lot Number: 334580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• 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
• Treatment: COUMADIN; INRATIO MONITOR, SN (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR