MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO2 PT MONITORING SYSTEM; PROTHROMBIN TIME TEST

Model Number 200432

Device Problems Nonstandard Device (1420); Low Test Results (2458)

Patient Problems Death (1802); Dementia (1808); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Pneumonia (2011); Test Result (2695); Fibrosis (3167)

Event Date 12/07/2014

Event Type  Injury  

Event Description

On (b)(4) 2015, a phone call was received from the patient's wife after she received the alere inratio pt/inr monitor system urgent medical device correction notification, dated (b)(4) 2014.She requested that alere home monitoring (ahm), the distributer, be notified that her husband would no longer be reporting results due to his death on (b)(6) 2015.The wife reported that she was not certain if the death was due to the inratio reading as the monitor would provide results lower than the laboratory results.In an attempt to obtain complete information, ahm was contacted and the following is a chronological history of available information and inratio inr results.(b)(6) 2014: started inratio testing.Therapeutic range: 2.0 - 4.0; (b)(6) 2014: no inratio inr; laboratory inr=1.35; (b)(6) 2014: inratio inr=3.1; no laboratory inr; (b)(6) 2014: inratio inr=3.8; no laboratory inr; (b)(6) 2014: inratio inr >7.5; lab inr=10.35 treatment included vitamin k 5mg orally and warfarin was held for 2 days.(b)(6) 2014: inratio=2.3 reported by ahm verses a 2.7 reported by wife (who performed the testing); no laboratory inr (unable to verify which inratio inr was the actual result).(b)(6) 2014: this date will be considered the date of event.The inratio monitor was not used after (b)(6) 2014 since the patient did not want his wife to perform further testing.(b)(6) 2014: patient was hospitalized for pneumonia; gout; lung infection and elevated inr.The laboratory inr was 7.0.There was no inratio inr testing performed.Treatment included stopping warfarin and breathing treatments.There was no hemorrhage or stroke.Patient was reported to have an l1 compression fracture and left ankle/foot pain.(b)(6) 2015: patient was discharged from the hospital to a nursing home and later returned to his home.Warfarin was not resumed after discharge.(b)(6) 2015: patient expired due to "senile dementia and pulmonary fibrosis".The report filing is due to the variability in the patient's results on (b)(6) 2014 and the required medical intervention.There is no information to suggest that the result variability caused or contributed to the subsequent death, which occurred over one (1) month after the reported event.Though requested, there was no additional information provided.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

Investigation/conclusion: there was initial confusion with the actual inratio value and date the last test was performed.The customer's wife reported that the last test performed on (b)(6) 2014 using the inratio monitor gave an inr value of 2.7.Additionally, alere home monitoring reported that the last test performed on (b)(6) 2014 gave an inr value of 2.3.However, upon reviewing the returned monitor's memory, the date of (b)(6) 2014 did not correlate with either initial reports.The last result obtained from the returned inratio monitor was dated (b)(6) 2005 with an inratio value of 2.8.The manufacturing records for the lot were reviewed and there were no issues related to this complaint.The products associated with the complaint were returned for investigation.Although the investigation of the returned monitor, using returned and retained strips, did not replicate the customer's complaint during testing, donor testing did not pass the accuracy and repeatability criteria and will be further investigated under capa-(b)(4).The investigation also found an impedance curve which exhibited a weak slope change.An impedance curve with a weak slope change has been identified in capa-(b)(4) to cause discrepant results.In addition, the capa investigation has determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins, acute inflammatory conditions and severe infections) such as the pneumonia and lung infection that the patient had at the time of the alleged discrepant result, can contribute to weak slope change impedance curves and is therefore, a possible root cause.The inratio monitor software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak slope change impedance curve.A notification letter has been sent to customers to inform them of these patient conditions.

• Brand Name: INRATIO2 PT MONITORING SYSTEM
• 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: 4578000
• MDR Text Key: 5550037
• Report Number: 2027969-2015-00155
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 200432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0880, 0881, 0882-2015
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED OTHER MEDICATION; INRATIO PT/INR TEST STRIPS 100071, LOT # 355401; WARFARIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR