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

Model Number 100071

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/09/2014

Event Type  Injury  

Manufacturer Narrative

Investigation/conclusion: since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.Internal investigation has determined that certain relevant conditions (e.G.Low hematocrit, sepsis) can contribute to discrepant inr results.The patient was reported to have renal disease requiring dialysis.This investigation has identified renal disease as a condition that may contribute to a discrepant inr result.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "unspecified discrepancy; inratio result was off by almost a full point.Pst hospitalized" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.If additional information is received, a supplemental medwatch form will be completed and submitted.

Event Description

This event was identified as part of an evaluation in which insurance claims/filed suits communicated to alere legal had not been forwarded to alere (b)(4) for investigation.There is limited information available regarding the event and due to the time gap between when the complaint was first reported to when alere (b)(4) was notified, additional information is not available.Complainant alleged that the patient "obtained unspecified discrepancy; inratio result was off by almost a full point.Patient hospitalized." there were no inr results or event description reported.The patient was hospitalized but stated that the readings on the monitor were not the only cause of his hospitalization.He also suffers from renal disease and is undergoing dialysis there is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "unspecified discrepancy; inratio result was off by almost a full point.Pst hospitalized" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.

• 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: 5096324
• MDR Text Key: 26466955
• Report Number: 2027969-2015-00695
• 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: company representative
• Reporter Occupation: Other
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: INRATIO MONITOR SN UNKNOWN
• Patient Outcome(s): Other