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

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Unspecified Infection (1930); Pain (1994); Misdiagnosis (2159); Patient Problem/Medical Problem (2688); Test Result (2695)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant low inratio value.Patient's therapeutic range: 2-3.On (b)(6) 2016, inratio inr = 2.5; lab inr = 7.0.Patient self tester had previous wound on foot.Patient tested morning of (b)(6) 2016, inratio= 2.5.Patient went to the hospital due to pain with foot 5 hours later.Hospital tested inr via lab draw: lab inr =7.0.Patient was admitted to hospital, due to infection in wound on foot.Per the patient, the infection was into the bone.Patient was immediately administered pain medication and coumadin was held based on lab result.Patient unsure if vitamin k was administered.Patient underwent surgery on foot, once inr returned to therapeutic range of 2.0-3.0, patient was unable to provide date.Surgery had been delayed until inr returned to therapeutic range.Patient resumed coumadin following surgery; unable to provide date.No additional information available.

Manufacturer Narrative

Additional report source: distributor.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 met release specifications.The patient indicated having osteomyelitis of the foot, which is a condition which may affect the action of oral anticoagulants and 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.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Manufacturer Narrative

Investigation/conclusion: it is indicated that the products associated with the complaint were 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 met release specifications.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: 5541714
• MDR Text Key: 41677584
• Report Number: 2027969-2016-00204
• 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,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• 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: 370105AR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention