MAUDE Adverse Event Report: UNOMEDICAL A/S AUTOSOFT 90 INFUSION SET; INSET INFUSION SET

Model Number 1002819

Device Problem Material Twisted/Bent (2981)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Event Description

Unomedical reference number: (b)(4).A (b)(6) -year old female diabetic (type 1) patient is receiving insulin treatment via a tandem insulin pump and a tandem autosoft 90 infusion set manufactured by unomedical.On (b)(6) 2021 she is found unresponsive by her grandchild who call an ambulance taking the patient to er and later icu.The infusion set was taken in use on (b)(6) 2021.Highest blood glucose (bg) measured at hospital was 1000 mg/dl.She was diagnosed with diabetic coma.Shortly before (previous day) she had received an injection with cortisone (indication unknown).She stays in hospital for five days before being released.Patient and grandchild suspect the cause of the incident to be a bent soft cannula and the cortisone injection.However no insulin pump alarm was registered.Unomedical find it unlikely that a bent cannula with no pump alarm(s) can have caused the very high bg of 1000 mg/dl.The infusion set that was used prior to hospitalisation has not been returned and made available for analysis/investigation.It is wellknown that injecting steroid in a diabetic person is likely to result in fast surging bg values that may well remain very high for 3-10 days.Injected steroid will inhibit (limit, decrease) the normal action of insulin's ability to control the blood glucose levels.

Manufacturer Narrative

A bent soft cannula is normally regarded as an insertion issue (i.E.User related).A bent soft cannula was not an observation but an assumption.

• Brand Name: AUTOSOFT 90 INFUSION SET
• Type of Device: INSET INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK-43 20; DA DK-4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK-43 20; DA DK-4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, DK-43-20
• MDR Report Key: 13496470
• MDR Text Key: 285321827
• Report Number: 3003442380-2022-00003
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018181
• UDI-Public: 05705244018181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032854
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1002819
• Device Lot Number: 5359714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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): Hospitalization; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Female