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 Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Nausea (1970)

Event Date 11/19/2014

Event Type  Injury  

Event Description

Information received from (b)(4).Report states client's son called and alleged inaccurate inratio readings.The last inratio inr was 2.6 on an unspecified date in 2015.No alternate testing values were reported.Patient's therapeutic range 2-3.Med watch report states patient was taken to the hospital on an unspecified date in 2014 for hard time breathing, nausea, and bleeding from mouth, nose and arms.Her inr was monitored constantly, oxygen therapy was given, and stents put in place in an unspecified location.No reported treatment for "bleeding from mouth, nose and arms".While the customer reported a variance between the inratio inr result and the lab inr result, no specified values were reported.Numerous attempt were made to contact the customer for additional information.All attempts were unsuccessful.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 the event; however, the customer did report that the inratio inr results were always within the therapeutic range.Based on the inability to rule out the possibility that the device may have caused or contributed to the bleeding event, this event is conservatively reported as a serious injury based on bleeding being potentially related to the patient's coagulation status; however, a device deficiency cannot be substantiated.

Manufacturer Narrative

Investigation conclusion: investigation pending.

Manufacturer Narrative

Investigation conclusion update: the customer did not provide a lot number or return any products for investigation.Unable to perform further investigation without additional information.Since the product associated with the complaint was not returned, manufacturing record review could not be performed and further investigation was not possible.

• 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: 4875056
• MDR Text Key: 15569292
• Report Number: 2027969-2015-00448
• 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,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2015

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/29/2015
• 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