MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC MINIMED MIO MMT-923A; INSULIN PUMP INFUSION SET

Model Number MMT-923A

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 01/04/2022

Event Type  Death  

Event Description

Unomedical reference: (b)(4).The following occured in (b)(6) and concern an incident with an english citizen using a medtronic minimed insulin pump with an infusion set, minimed mio model mmt-923a, manufactured by unomedical.A female diabetic type i patient is brought to hospital (b)(6) unresponsive, comatose and in heart arrest approximately at 17:30 on (b)(6) 2022 with a blood glucose (bg) of 33+ mmol/l or (and probably) higher.The husband had seen to her at around 16:00 and found her unresponsive at 17:00 when he called for an ambulance.Patient was revived (pulse and breathing) after some 30 mins of emergency treatment.Prior to this, the patient changed infusion set at 23:00 on (b)(6) 2022 with a bg of 13.9 mmol/l.4 hours later bg was at 12.7 mmol/l.Then follows a period of 32 hours during which 9 bg measurements are steadily rising to max of 33 mmol/l at 11:55 noon time on (b)(6) 2022.In this period a total of 73.4 units of insulin is taken to counteract the rising bg.Patient's normal total daily dose is 30 units.At approximately 17:00 on (b)(6) 2022 after almost 24 hours in hospital the patient is declared brain-dead and all hospital treatment is stopped.The insulin pump history has been retrieved.No 'non-delivery' or 'blocked' alarms were found.No infusion set(s) has been retained and sent to unomedical for examination and analysis.Infusion set lot number is unknown.No available data indicate any infusion set failure/malfunction.As per standard training of insulin pump users only a maximum of two unsuccessful attempts by patient/spouse to bring down too high bg values is allowed before hcp assistance should be sought.Unomedical will not attempt any further causality assessments as far as root cause and the final, sad outcome is concerned.We do not expect to receive further relevant information on this incident.Nevertheless, should such information become available, we will re-open the case and submit a follow-up emdr to fda.

Manufacturer Narrative

N/a.

• Brand Name: MEDTRONIC MINIMED MIO MMT-923A
• 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: 13479430
• MDR Text Key: 285220820
• Report Number: 3003442380-2022-00002
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-923A
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death; Hospitalization
• Patient Sex: Female