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

Model Number 100071

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Type  Death  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.Additionally, a lot number of the test strip product was not provided and neither manufacturing record review nor testing on reserve sample from the same lot could not be performed.Further investigation is not possible at this time.Alere has withdrawn the alere inratio®/inratio®2 pt/inr system from the market and is no longer manufacturing alere inratio® test strips and monitors.In addition, all alere inratio® test strips are now expired.Customers have been advised to work with their healthcare provider to transition to an alternative monitoring method, such as a plasma-based laboratory inr method or a point-of-care monitoring system from a different manufacturer.

Event Description

Information was received regarding the death of a patient due to hemorrhage.Information alleged the involvement of an inratio system.However, no deficiency was specified and no additional information provided.Information alleged the involvement of an inratio system.However, no product deficiency was specified.There is insufficient evidence to reasonably suggest a device malfunction occurred.Furthermore, although there is no information directly linking the patient's death to use of the inratio system, this mdr is being conservatively filed as a hemorrhage is a potential coagulation-related event.

• 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: 7920347
• MDR Text Key: 122111939
• Report Number: 2027969-2018-00125
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2018
• 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: Z-2354, 2362-2016
• Patient Sequence Number: 1
• Treatment: INRATIO2 MONITOR, PN 200432, (B)(4)
• Patient Outcome(s): Death; Life Threatening