MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO; PROTHROMBIN TIME TEST

Model Number 100137

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Death (1802); Embolism (1829); Transient Ischemic Attack (2109); Collapse (2416)

Event Date 01/05/2014

Event Type  malfunction  

Event Description

The customer's wife called to report potential discrepant inratio inr results and that her husband expired on (b)(6) 2014.The husband's therapeutic range was 2.0 - 2.5.He was reported to be "slightly anemic"; however, no results were provided.The following is a chronological history of the available information.(b)(6) 2014: inratio=2.2, (b)(6) 2014: inratio=2.2, (b)(6) 2014: inratio=1.8, (b)(6) 2014: inratio=2.4, (b)(6) 2014: inratio=1.6, (b)(6) 2014: inratio=2.1, (b)(6) 2014: hospitalized after getting out of bed and collapsing.There were no laboratory inr results provided at the time of hospitalization.The wife reported that the medical staff told her the inr was "high".(b)(6) 2014: discharged from hospital.Customer was switched from generic warfarin 4-5mg daily to coumadin 4-5mg daily.(b)(6) 2014: inratio=1.9, (b)(6) 2014: inratio=2.3, (b)(6) 2014: inratio=2.0, (b)(6) 2014: inratio=2.5, (b)(6) 2014: inratio=2.1, (b)(6) 2014: the customer expired.Per death certificate, the cause of death, was complications from embolic stroke.There is no information available to suggest that the device caused or contributed to the reported event.This event is conservatively reported due to alleged deficiency that cannot be substantiated without access to additional data or results.Multiple attempts were made to obtain additional information; however, no further information was provided.

Manufacturer Narrative

Investigation/conclusion: the customer's wife provided multiple inratio inr results without providing laboratory reference results.The monitor and inratio test strips associated with the complaint were returned for investigation.The customer's complaint of discrepant results was not replicated with the returned monitor and strips using in-house donors.A review of the manufacturing records for the lot did not uncover any non-conformances and the lot met release specification.The monitor's memory was reviewed.The impedance curve for the inratio inr result of 2.1 from (b)(6) 2014 was retrieved.The impedance curve was analyzed statistically to determine if it contained a weak slope change.The impedance curve associated with the result of 2.1 from (b)(6) 2014 exhibited a weak slope change.Capa investigation (capa (b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.The capa investigation has also determined that certain patient conditions (e.G.Low hematocrit, elevated plasma proteins) can contribute to weak slope change impedance curves.The customer reported that the patient was "slightly" anemic but a hematocrit value was not provided.A notification letter has been sent to customers to inform them of these patient conditions.The patient passed away on (b)(6) 2014 from complications from an embolic stroke ("clot"), which suggests that the patient's inr value may have been lower than the inr value reported on the inratio monitor.The outcome, of embolic stroke, is typically associated with a patient status of under anti-coagulation.The inratio system reported results that showed the patient was within their therapeutic range, and in some cases, below their therapeutic range.These inr results are not inconsistent with a patient status of under anti-coagulation.Because a reference lab result was not provided, we cannot conclude that the inr result of 2.1 (which was associated with a weak slope change curve) was a discrepant result.

• Brand Name: INRATIO
• 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: 4667754
• MDR Text Key: 5733912
• Report Number: 2027969-2015-00246
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020679
• 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
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 04/08/2015
• 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: WARFARIN 4-5MG DAILY STOPPED APPROX. (B)(6) 2014; PRAZOSIN 1MG DAILY IN LATE AFTERNOON; COUMADIN 4-5MG DAILY; TERAZOSIN 5MG DAILY IN EVENING; IRON EVERY OTHER DAY; INRATIO PT/INR TEST STRIPS 100139, LOT# K318141; SOTALOL 80MG IN AM
• Patient Age: 79 YR