MAUDE Adverse Event Report

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.

Event Text Entries

[187072520] 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

[187072521] It was reported that the patient had been hospitalized with hypoglycemia. The patient's blood glucose levels were in the 40 mg/dl range while wearing the pod between 4 and 24 hours. The patient consumed some brown sugar, juice and glucose tablets. The patient had changed the personal diabetes manager settings while at work by decreasing insulin doses by 75 percent and back to 100 percent today. Once at the hospital the patient was treated with intravenous fluids, glucagon and ondansetron. The patient's blood glucose and insulin history are as follows: (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3004464228-2020-04724
MDR Report Key9908754
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-03-11
Date Mfgr Received2020-03-12
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJORDAN BISWURM
Manufacturer Street100 NAGOG PARK
Manufacturer CityACTON MA 01720
Manufacturer CountryUS
Manufacturer Postal01720
Manufacturer Phone9786007000
Manufacturer Street100 NAGOG PARK
Manufacturer CityACTON MA 01720
Manufacturer CountryUS
Manufacturer Postal Code01720
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeLZG
Date Received2020-03-31
Model Number14000
Catalog NumberZXP425
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer Address100 NAGOG PARK ACTON MA 01720 US 01720


Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-31

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