Model Number MMT-7008A |
Device Problems
Inaccurate Delivery (2339); Incorrect Or Inadequate Test Results (2456)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
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Event Description
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The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s states its telling me low and it will suspend but my blood glucose was 70 points higher.Insulin delivery was suspended due to sensor values.Sensor value that triggered the suspend event was 87 mg/dl.Suspend on low limit in sensor settings was 90 mg/dl.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.The sensor will not be returned for analysis.
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Manufacturer Narrative
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Inspected one random opened/used sensor and performed continuity resistance test found sensor passed per specifications and performed the sensor initialization test using a new lab transmitter with a paradigm pump.Connected the sensor to the transmitter and placed it in 100 bts solution, confirmed the communication icon was displayed and that the transmitter was flashing while connected to the sensor.The sensor functioned properly.Cannot perform bts test as the sensor is beyond its expiration date.
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Search Alerts/Recalls
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