MAUDE Adverse Event Report: ALERE INRATIO

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Overdose (1988)

Event Date 01/08/2015

Event Type  Injury  

Event Description

Patient was being monitored for anticoagulation status post pulmonary embolism by the (b)(6) we had patient referred to.Result came back as an inr of 3 but when we asked how the result was obtained we were told they used the alere inratio monitor.We asked that another method of testing be used and another inr monitor from a different mfr was used.At this point the result was an inr of 8.We sent the patient immediately to the emergency dept where she was treated for over anticoagulation with vitamin k.This caused increase expense and put the patient at risk or excessive bleeding should she have had an injury.In addition, we had to monitor her closely for a week after that until the effects of the vitamin k wore off the we once again had an accurate reading of her inr.We had been treating this patient for weeks based on erroneous results obtained from the alere monitor.This should not be tolerated.In addition, the company has not even offered to help us pay for a different machine so we could accommodate all of our patients' needs.

• Brand Name: INRATIO
• Type of Device: INRATIO
• Manufacturer (Section D): ALERE; san diego CA
• MDR Report Key: 4570300
• MDR Text Key: 5458842
• Report Number: MW5041135
• Device Sequence Number: 1
• Product Code: GJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2015

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 54 YR
• Patient Weight: 84