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

Model Number 99008G1

Device Problem High Test Results (2457)

Patient Problems Renal Failure (2041); Loss of Vision (2139)

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio values.Event occurred in (b)(6).Patient's therapeutic range 2 - 3.On (b)(6) 2016 patient's wife reported discrepant high inratio results compared to laboratory inr results.The patient is currently in a rehab clinic recovering from a stroke event.Follow-up with the patient's wife and rehab clinic confirmed the following: before stroke event: there is no known evidence for discrepant inratio results prior to the stroke.The patient's wife recalled they did one comparison a longer time ago and it was comparable to the lab results.No details known.Stroke event: the patient was hospitalized due to a stroke on (b)(6) 2016.Patient was moved to the normal station on (b)(6) 2016.Patient left the hospital on (b)(6) 2016.It is reported the patient has no paralysis, no verbal disabilities.A slight loss of vision (vision at 80%), which is receding and improving.It is alleged by the patient's physician that the patient had a traumatic brain injury and - because of the cardiogenic shock - renal failure.The patient's physician alleges that the patient's phenprocoumon dosage was too low because of the high results given by the inratio meter.(note: no inratio results were reported prior to the stroke.) first reported inratio result was on (b)(6) 2016, approximately three weeks after patient's stroke, inratio inr = 2.7; lab inr = 1.9.(b)(6) 2016 inratio inr = 2.2; lab inr = 1.5.Unknown date: the physician from the rehab clinic reported the following result.Inratio inr = 4.8, lab inr = 1.9 although the date was not provided, this result was likely post stroke as it was reported by the rehab clinic.Additional results were tested on a different lot: on (b)(6) 2016 inratio inr (lot #k382425) = 4.3; inratio inr (lot #k385431) = 3.8; laboratory inr = 2.9.On (b)(6) 2016 inratio inr (lot #k382425) = 4.2; inratio inr (lot #k385431) = 3.5.No lab comparison was taken on this unspecified date.This event is being filed as a malfunction due to the discrepant results after the stroke event.There is no information available to suggest that the inratio device caused or contributed to the reported stroke and subsequent patient outcome.There was no additional information provided.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the in-house testing history of strip lot k382425 was performed.In-house testing on the strip lot met release criteria and the product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Although a technique issue was identified in the complaint which may have contributed to the discrepant results obtained by the customer, a root cause could not be determined from the available information.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

• 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: 5690092
• MDR Text Key: 47307455
• Report Number: 2027969-2016-00406
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 99008G1
• Device Lot Number: K382425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1