Model Number MMT-XXX |
Device Problems
Device Inoperable (1663); Electromagnetic Compatibility Problem (2927)
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Patient Problem
Hypoglycemia (1912)
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Event Date 09/29/2015 |
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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Customer called and reported that they received emergency medical assistance due to high blood glucose around (b)(6) 1998 with blood glucose of 700 mg/dl at the time of the incident.The customer was flying to france and went through a metal detector.Her pump stopped working while on the flight, and she had to use manual injections and went to the hospital when she landed.The customer used manual injections and was put on intravenous insulin to treat.The customer experienced diabetic ketoacidosis.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed as the pump is no longer available.Customer has been hospitalized 10 times for lows and highs, but can only remember 5 hospitalizations.The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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The information provided were incorrect with the initial report.The correct information has been provided with this report.
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Event Description
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The customer reported via phone call that they were hospitalized on (b)(6) 2015.Customer's blood glucose level was not reported.She was in the hospital and had open heart surgery in (b)(6) of 2015.When she was recovering afterwards she had issues with blood glucose levels dropping like crazy.She was in the hospital and on the insulin pump.She was going to bathroom with someone helping her and then she remembers she was passed out with people helping her back to the bed.The customer was supposed to go home after about a week and was kept for about 10 days because sugars were so low.In the hospital the customer was able to eat and juice.The customer was wearing the insulin pump during the incident.The device was not returned.
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Search Alerts/Recalls
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