Model Number MMT-7008A |
Device Problems
False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)
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Patient Problem
Hypoglycemia (1912)
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Event Date 02/25/2018 |
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 the customer¿s blood glucose was low and the sensor had inaccurate readings that triggered threshold suspend alarm.
The customer¿s blood glucose was 143 mg/dl and the sensor glucose was 55mg/dl at the time of the incident.
The customer reported that sensor glucose and blood glucose difference is not within acceptable range.
Insulin delivery was suspended due to sensor glucose value of 52mg/dl.
Low suspend limit in sensor settings was 70.
Customers current blood glucose was 200mg/dl.
Customer states the drive support cap appears normal.
Based on customer report proceeding in troubleshooting the customer was alleging possible pump over delivery.
The customer¿s blood glucose was 93mg/dl.
Also sensor glucose was 135mg/dl when blood glucose 97mg/dl.
The customer also reported sensor glucose value of 71mg/dl and then blood glucose 128mg/dl.
Also blood glucose was 170mg/dl.
The sensor will be returned for analysis.
The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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The information provided in concomitant reporting section with the initial report was incorrect.
The correct information has been included with this report.
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Search Alerts/Recalls
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