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 INSULIN PUMP 14000 ZXP425 manufactured by Insulet Corporation.
[187071526]
The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported [er visit/hospitalization] and hypoglycemia. No lot release records were reviewed, as the product lot number was not provided. Omnipod insulin management system? User guide. Model: ust400. 17845-5a-aw rev b 09/17. Checking your blood glucose. Chapter 4 / page 36. Warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia). Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia). If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), repeat the test. If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider. Living with diabetes. Chapter 11 / page 119. Hypoglycemia can occur even when a pod is working properly. Never ignore the signs of low blood glucose, no matter how mild. If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness. If you suspect that your blood glucose level is low, check your blood glucose level to confirm.
Patient Sequence No: 1, Text Type: N, H10
[187071527]
It was reported that the patient had been hospitalized with hypoglycemia. The patient's blood glucose levels were in the 50 mg/dl range while wearing the pod between 24 and 36 hours. Prior to going to the hospital the patient administered a bolus of 1. 2 units of insulin. At the hospital the pod was removed and. The patient was treated by hydration and prescribed zofran to be taken every 8 hours for 4 days. The patient's blood glucose and insulin history are as follows: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004464228-2020-04723 |
| MDR Report Key | 9908749 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-12 |
| 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 INSULIN PUMP |
| Generic Name | PUMP, INFUSION, INSULIN |
| Product Code | LZG |
| Date Received | 2020-03-31 |
| Model Number | 14000 |
| Catalog Number | ZXP425 |
| 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 | 2020-03-31 |