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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)

Event Date 12/13/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Patient self tester's daughter called reporting discrepant inratio values.Patient's therapeutic range 2.5 - 3.5.(b)(6) 2015 inratio inr = 3.0.(b)(6) 2015 lab inr = 7.0.(b)(6) 2015 patient went to hospital due to stomach issues and diarrhea and was diagnosed with severe bladder infection.Patient's daughter indicated that the hospital may have over dosed patient and had patient take 10mg of coumadin which may have caused elevated inr.Patient was given unspecified antibiotics at the hospital.Patient released from hospital on (b)(6) 2015.Patient has had unspecified results within therapeutic range, after release from hospital.Exact dates and results not provided.No additional information provided.

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire testing history for the reported lot was performed.In-house testing on strip lot 370105ar meets release criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any relevant non-conformances.The lot meets release specification.It was reported that the patient has a severe bladder infection.Certain medical conditions including severe infections may impact the performance of the assay.Although a potential patient sample interference was identified, a root cause could not be determined from the information provided by the customer.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: 5384256
• MDR Text Key: 36771024
• Report Number: 2027969-2016-00041
• 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
• Type of Report: Initial,Followup
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: 370105AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: No
• 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