Model Number MMT-7008A |
Device Problems
False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)
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Patient Problem
Blood Loss (2597)
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Event Date 10/19/2017 |
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 the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 143 mg/dl and the sensor glucose was 60 mg/dl at the time of the incident.The customer reported that they changed the sensor.The customer stated that the insulin pump was suspended.The sensor will be returned for analysis.
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Manufacturer Narrative
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Inspected one opened/used sensor and performed continuity resistance test and sensor passed per specifications.Performed bicarbonate buffer test and sensor passed per specifications.Found cannula bent unable to confirm customer received sensor in said condition due to customer return sensor opened/used.
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Search Alerts/Recalls
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