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 Problems Bruise/Contusion (1754); Death (1802)

Event Date 12/13/2014

Event Type  Death  

Event Description

On (b)(6) 2015, a phone call was received from the patient's husband after he received the alere inratio pt/inr monitor system urgent medical device correction notification, dated (b)(6) 2014.He reported that his wife had the majority, if not all, of the conditions that were listed in the notification and that his wife expired on (b)(6) 2014.Additionally, she was "visibly black and blue with bruising" and that the attending physician at the hospital suggested that "it was an issue with the coumadin and the strips".The patient's husband did not feel that he could, with any accuracy, be more specific.He was unable to provide the exact cause of death, any results obtained on the inratio system prior to (b)(6) 2014, laboratory results, medications, test techniques, lot or serial information on the device.He did not wish to discuss any medical conditions but indicated that there were a lot of things going on with his wife and that she was "very, very, very sick".The distributer, philips remote cardiac services, was contacted in an attempt to obtain additional information.The distributer reported that the monitor was returned to them in (b)(6) 2015 and was "scrapped" per their internal procedure since it had been over sixty (60) days.Though requested, there was no additional information provided.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The customer could not provide information regarding details of the event.This event is conservatively reported due to alleged deficiency that cannot be substantiated without access to additional data or results.

Manufacturer Narrative

Investigation/conclusion: the patient's husband did not provide a lot number or return the device for investigation.The patient's husband reported bruising and the "majority" of the medical conditions listed in the alere inratio pt/inr monitor system urgent medical device correction notification, dated (b)(6) 2014, which was sent to customers.Internal investigation has determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to discrepant inr results.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.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The customer could not provide information regarding details of the event.This event is conservatively reported due to alleged deficiency that cannot be substantiated without access to additional data or results.

• 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: 4686342
• MDR Text Key: 16993692
• Report Number: 2027969-2015-00259
• 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,Distributor
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/17/2015

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: 03/17/2015
• Initial Date FDA Received: 04/13/2015
• 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
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: COUMADIN; INRATIO MONITOR SN (B)(4)
• Patient Outcome(s): Death
• Patient Age: 69 YR