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 Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: further investigation cannot be pursued because there is no lot/serial number.

Event Description

Report received of unspecified discrepant inratio values.Patient's therapeutic range 2.5 - 3.5.Patient self tester's daughter called requesting additional inratio test strips.The inratio product requested is being removed from the market (recall #z-2354 - z-2362-2016).No complaint allegations were made initially during the call.Patient had been transitioned to roche coaguchek.Although requested, it is unknown when the transition to coaguchek occurred.Therefore, any inr results provided may be from either the inratio system, roche system or potentially both systems.Patient's daughter stated her father was blind in one eye and the new coaguchek device was too small for him.Patient's daughter stated her father was currently in the hospital, due to fluctuating inr and cancer.Inr results were obtained from (b)(6) 2008 through (b)(6) 2016, however, it is unknown whether inratio or coaguchek was used.No comparative lab results were reported.There is no information available to confirm an adverse event and/or malfunction occurred or that the device caused or contributed to the reported event.With no laboratory inr results for comparison, it is unknown if discrepant results were received.Based on the inability to rule out the possibility that the device may have caused or contributed to the reported hospitalization and fluctuating inr results (unknown if inratio, roche or other device), this event is being conservatively reported as an adverse event based on the hospitalization potentially related to the patient's coagulation status; however a device deficiency cannot be substantiated.There was no additional information provided.

• 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: 6045959
• MDR Text Key: 58018662
• Report Number: 2027969-2016-00662
• 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,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/22/2016

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/20/2016
• 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
• Removal/Correction Number: Z2354-2016 Z2362-2016
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR SERIAL # UNKNOWN
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR