MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT/INR PROFESSIONAL TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 99008G1

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Coagulation Disorder (1779); Death (1802); Heart Failure (2206)

Event Date 09/12/2015

Event Type  Injury  

Manufacturer Narrative

Although the device is not available for evaluation, investigation to determine a potential malfunction is pending.A review was performed by alere's medical advisor to determine if there is any association between the inratio device and the event.Based on the information provided, including the physician's statement that indicated bleeding did not contribute to the patient's death but that the cause of death was heart failure, there is no reasonable suspicion that the inratio device caused or contributed to the patient's death.

Event Description

A physician customer reported two variances between a patient's inratio inr results from poc testing and laboratory inr results.Both reported discrepant results were obtained during the same week (exact dates unknown).The results are as follows: event 1: inratio 1.9, lab >5.8, event 2: inratio 2.1, lab >8.Patient's therapeutic range was: 2-3.Patient was hospitalized on (b)(6) 2015 and given vitamin k.According to the physician, the patient was multimorbid, suffering from many different diseases including renal insufficiency and water in the lung.The physician reported that the patient died from heart failure and that the death was not due to a bleed.The physician also reported that the patient's hematocrit was 38% prior to hospitalization and 39% in the hospital (range per package insert is 25-53%).Although requested, no additional information about the hospital, hospitalization dates, or date of death could be obtained, nor could a copy of the patient's death certificate be obtained.Note: this mdr filing is due to the device being the same or similar to a device available in the us.

Manufacturer Narrative

The monitor associated with the complaint was not returned for investigation.As a result, retained strips from lot k372403 were tested with in-house monitors.The customer's complaint was not replicated during in-house investigation.A review of the entire lot testing history was performed and the lot met expectations.A review of the manufacturing records for lot k372403 did not uncover any relevant non-conformances.Lot meets release specifications.The impedance curves for the reported inratio inr results could not be analyzed because the monitor was not returned for investigation.A root cause could not be determined from the information provided by the customer.

• Brand Name: INRATIO2 PT/INR PROFESSIONAL TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 5231055
• MDR Text Key: 31453642
• Report Number: 2027969-2015-00933
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

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
• Device Model Number: 99008G1
• Device Lot Number: K372403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention