MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC SILHOUETTE MMT-368A; INSULIN PUMP INFUSION SET

Model Number MMT-368A

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 01/11/2022

Event Type  Death  

Event Description

Unomedical reference: (b)(4).The following occur in (b)(6) and concern an incident with a (b)(6) citizen.A female diabetic type i patient is brought to hospital (b)(6) in the morning of (b)(6) 2022 with a blood glucose of 2.7 (bg value unit presumably mmol/l), ketoacidosis, unresponsive in coma.Pump alarmed non-delivery 03:06 - 03:18.Medtronic is replacing pump, insulin reservoir, cgm sensor and infusion set (minimed silhouette mmt-368a).Note: under-delivery of insulin will lead to hyperglycemia - here hypoglycemia is reported.Unexplainable unless '2.7' is a typing error or is correct but is the result of far to much insulin supplied by extreme over-bolusing in attempt(s) to correct a hyperglycemia.No further data available at this moment.Present data does not allow unomedical to assess causality.We will try to obtain further data on the incident.

Manufacturer Narrative

On (b)(6) 2022: further incident information is sought.If successful a follow-up report will be submitted.

Manufacturer Narrative

19jan2022: further incident information is sought.If successful a follow-up report will be submitted.04feb2022: follow-up1 - see the amended description in section b 5.08feb2022: follow-up2 - added final outcome (died on (b)(6) 2022) primarily see the amended description in section b 5.

Event Description

Unomedical reference: (b)(4).The following occur in switzerland and concern an incident with a swiss citizen.A female diabetic type i patient is brought to hospital (b)(6) in the morning on (b)(6) 2022 with a blood glucose of 2.7 (bg value unit presumably mmol/l), ketoacidosis, unresponsive in coma.Pump alarmed non-delivery 03:06 - 03:18.Medtronic is replacing pump, insulin reservoir, cgm sensor and infusion set (minimed silhouette mmt-368a).Note: under-delivery of insulin will lead to hyperglycemia - here hypoglycemia is reported.Unexplainable unless '2.7' is a typing error or is correct but is the result of far to much insulin supplied by extreme over-bolusing in attempt(s) to correct a hyperglycemia.No further data available at this moment.Present data does not allow unomedical to assess causality.We will try to obtain further data on the incident.Update per on (b)(6) 2022: the insulin pump is a medtronic 670g model.The low blood glucose value of 2.7 mmol/l has been confirmed (value and units).Patient had attempted to correct high blood glucose with her fallback medication of pen-based insulin.We assume that this resulted in too much insulin being administered multiple times and too fast thus leading to hospital admission with severe hypoglycemia and coma.We remain unable to assess what led to the initial pump alarm of no-delivery.Update per on (b)(6) 2022: we re-open the case as we have just received further information from medtronic local staff: sadly the patient, mrs pxxxxxxx, never regained consciousness and died in hospital (b)(6).If further relevant information (such as e.G.Pump data possibly including cgm ascensia sensor bg readings) becomes available, we will again re-open and update the case and submit a new follow-up emdr to fda.

Event Description

Unomedical reference: (b)(4).The following occur in switzerland and concern an incident with a swiss citizen.A female diabetic type i patient is brought to (b)(6) hospital in the morning of (b)(6) 2022 with a blood glucose of 2.7 (bg value unit presumably mmol/l), ketoacidosis, unresponsive in coma.Pump alarmed non-delivery 03:06 - 03:18.Medtronic is replacing pump, insulin reservoir, cgm sensor and infusion set (minimed silhouette mmt-368a).Note: under-delivery of insulin will lead to hyperglycemia - here hypoglycemia is reported.Unexplainable unless '2.7' is a typing error or is correct but is the result of far to much insulin supplied by extreme over-bolusing in attempt(s) to correct a hyperglycemia.No further data available at this moment.Present data does not allow unomedical to assess causality.We will try to obtain further data on the incident.Update per 04feb2022: the insulin pump is a medtronic 670g model.The low blood glucose value of 2.7 mmol/l has been confirmed (value and units).Patient had attempted to correct high blood glucose with her fallback medication of pen-based insulin.We assume that this resulted in too much insulin being administered multiple times and too fast thus leading to hospital admission with severe hypoglycemia and coma.We remain unable to assess what led to the initial pump alarm of no-delivery.If further relevant information becomes available we will re-open and update the case and submit a new follow-up emdr to fda.

Manufacturer Narrative

19jan2022: further incident information is sought.If successful a follow-up report will be submitted.04feb2022: this is follow-up - see the amended description in section b 5.

• Brand Name: MEDTRONIC SILHOUETTE MMT-368A
• Type of Device: INSULIN PUMP INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3, osted; lejre, 4320
• MDR Report Key: 13288079
• MDR Text Key: 284000538
• Report Number: 3003442380-2022-00001
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019492
• UDI-Public: 05705244019492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-368A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Death; Life Threatening
• Patient Sex: Female