Model Number MMT-7008A |
Device Problems
Under-Sensing (1661); Device Operates Differently Than Expected (2913)
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Patient Problem
Hypoglycemia (1912)
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Event Date 06/02/2018 |
Event Type
Injury
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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 that their insulin pump inappropriately suspended due to a sensor glucose of 50 mg/dl despite a blood glucose of 130 mg/dl.Troubleshooting did not resolve the issue.The sensor will be returned for analysis.
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Manufacturer Narrative
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Inspected 1 opened sensor and performed continuity resistance test and sensor passed per specifications.Performed the sensor initialization test using a new lab transmitter with 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.Sensor passed per specifications.Cannot perform bts test as the sensor is beyond its expiration date.
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Search Alerts/Recalls
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