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 Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Testing using reserve product from the same lot and a review of manufacturing records could not be performed as no lot number was provided.No further investigation can be pursued at this time.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The patient reported the following events following use of the inratio system: the patient experienced excessive anti-coagulation which led to right sided intrathoracic hematoma and a laboratory inr result of >9.5.As a result, the patient was hospitalized for empyema, hemothorax and respiratory distress.The patient alleges that he was incapacitated from pursuing his normal activities and will continue to experience pain and suffering.No additional information was provided.

Manufacturer Narrative

(describe event or problem) updated to include information regarding medical records received 09/15/2017.

Event Description

The patient reported the following events following use of the inratio system: the patient experienced excessive anti-coagulation which led to right sided intrathoracic hematoma and a laboratory inr result of >9.5.As a result, the patient was hospitalized for empyema, hemothorax and respiratory distress.The patient alleges that he was incapacitated from pursuing his normal activities and will continue to experience pain and suffering.No additional information was provided.On 09/15/2017, extensive medical records were received regarding this event.The medical records describe the same event and no new complaint is alleged.There is no reported information that would alter the initial mdr reporting decision or mdr filed.

• 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: 6642243
• MDR Text Key: 77606178
• Report Number: 2027969-2017-00097
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• 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
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

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 Model Number: 100071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 10/11/2017
• 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
• Patient Outcome(s): Hospitalization