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

Model Number 100007

Device Problems Use of Incorrect Control/Treatment Settings (1126); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 01/12/2015

Event Type  Injury  

Event Description

Caller alleged discrepant inratio results.Results as follows: date, inratio, lab: (b)(6), 2.3, -; (b)(6), -, 7.4; (b)(6), 3.5.Therapeutic range: 2.5-3.5 the patient self tester took their normal dose of coumadin (2.5 mg) the nights of (b)(6).The patient went to the lab on (b)(6) but did not receive the results until (b)(6).After receiving the lab result the patient was instructed to hold their coumadin for three days.Caller reports adding multiple drops of blood to the tests strip and the meter not being in the correct mode when the finger stick was performed.

Manufacturer Narrative

The products associated with the complaint were returned for investigation.The complaint of a discrepant low result was not replicated when the returned meter and strips were tested using in-house donors.The manufacturing records for the lot were reviewed.The non-conformance associated with this lot was not relevant to the initial complaint and does not affect product performance.The impedance curve analysis associated with this case exhibited a weak slope change.Our capa investigation ((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 patient had crohn's disease and rheumatoid arthritis at the time of the alleged discrepant result.Capa (b)(4) has identified crohn's disease and rheumatoid arthritis as conditions that may contribute to a discrepant inr result.These medical conditions may be a possible root cause.Further investigation into these issues will be pursued under (b)(4).A notification letter has been sent to customers to inform them of these patient conditions.

Manufacturer Narrative

During thermometer sensing on the unit, both heater plate thermistors failed to meet specification.Statistical analysis of testing performed as part of an extended complaint failure investigation (reference (b)(4)) found there to be no significant difference in inr values between returned meters that failed the heating specification and meters that passed the heating specification.

Manufacturer Narrative

Additional information: investigation of the returned meter resulted in successful passing of functional testing, but failure in thermistor heater plate testing.Thermistors a and b both failed to meet specification.Weak slope change: a possible root cause is the patient conditions of crohn's disease and rheumatoid arthritis which may have contributed to an impedance curve that exhibited a weak-slope change.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.

• Brand Name: INRATIO SELF-TEST PT MONITORING SYSTEM
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4495464
• MDR Text Key: 20073020
• Report Number: 2027969-2015-00085
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2015

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: Lay User/Patient
• Device Model Number: 100007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2015; 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: MEDICATIONS: COUMADIN, HUMIRA, TYLENOL WITH CODEIN; TEST STRIP LOT NUMBER: 354045
• Patient Outcome(s): Required Intervention