MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for OMNIPOD DASH? INSULIN MANAGEMENT SYSTEM 18320 BLE-I1-529 manufactured by Insulet Corporation.
[187072369]
The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported er visit and diabetic ketoacidosis with hyperglycemia. Lot release records were reviewed and the product lot met all acceptance criteria. Omnipod dash insulin management system? User guide. Model: 18320. 18296-eng-aw rev b 06/18. Changing your pod. Chapter 3 / page 37. Warnings: do not use a pod if you are sensitive to or have allergies to acrylic adhesives, or have fragile or easily damaged skin. Living with diabetes. Chapter 13 / page 171. Infusion site checks at least once a day, use the pod's viewing window to inspect the infusion site. Check the site for: leakage or scent of insulin, which may indicate the cannula has dislodged. Signs of infection, such as pain, swelling, redness, discharge, or heat.
Patient Sequence No: 1, Text Type: N, H10
[187072370]
It was reported that the patient's blood glucose (bg) values reached 555 mg/dl. The patient went to the emergency room, where they were diagnosed with diabetic ketoacidosis (dka). The patient was given intravenous (iv) fluids and blood work was given, as treatment. The patient reported that the adhesive was lifted where the cannula is located and the cannula was dislodged, as a result. The patient changed out the pod for a new pod.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004464228-2020-04722 |
| MDR Report Key | 9908746 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-08-02 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JORDAN BISWURM |
| Manufacturer Street | 100 NAGOG PARK |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Manufacturer Phone | 9786007000 |
| Manufacturer G1 | INSULET CORPORATION |
| Manufacturer Street | 100 NAGOG PARK |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01720 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPOD DASH? INSULIN MANAGEMENT SYSTEM |
| Generic Name | PUMP, INFUSION, INSULIN |
| Product Code | LZG |
| Date Received | 2020-03-31 |
| Model Number | 18320 |
| Catalog Number | BLE-I1-529 |
| Lot Number | PD1C08021951 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSULET CORPORATION |
| Manufacturer Address | 100 NAGOG PARK ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |