Model Number MMT-751NAH |
Device Problems
Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)
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Patient Problems
Hypoglycemia (1912); Overdose (1988)
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Event Date 08/23/2015 |
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.(b)(4).
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Event Description
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The customer's mother reported via phone call of a bolus wizard on the insulin pump.The customer's mother stated that the pump was giving the wrong amount of insulin on the pump 2 times.The customer's mother stated that the pump gave the wrong correction and cancelled the deliveries before they occurred.The customer's mother felt the pump will deliver too much insulin causing the customer to have a low blood glucose reading.The customer will be sent a replacement pump.
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Manufacturer Narrative
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The insulin pump was programmed bolus wizard feature with blood glucose of 140 mg/dl, 70 grams food intake and it's estimated of 2.65 units.The unit was delivered 2.65 units correctly and recorded in bolus history screen.No bolus wizard anomaly noted.The insulin pump had minor scratched lcd window and cracked reservoir tube lip.
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Search Alerts/Recalls
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