|
Model Number 14000 |
Device Problem
Bent (1059)
|
Patient Problems
Hyperglycemia (1905); Pain (1994)
|
Event Date 06/09/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was not returned for evaluation.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.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.
|
|
Event Description
|
It was reported that a patient's blood glucose levels reached 350 mg/dl while wearing the pod between 4 and 24 hours.When removed from the infusion site (abdomen), the pod's cannula was found bent.As treatment, a manual injection of insulin (3u) was delivered and a new pod was applied.It should be known that, during insertion, patient experienced pain.
|
|
Manufacturer Narrative
|
The device was returned with damage to the exterior and interior of the device.The soft cannula was returned bent into the cannula window.When the device was opened to perform the investigation, the ratchet gear could not be turned because one of the hook talons was bent into the ratchet gear.The batteries in the device were returned depleted.The pcb (printed circuit board) was removed from the device and connected to an external battery in an attempt to download the data from the device.No damage was found on the pcb, but the data could not be downloaded from the device after being connected to the external battery.Corrosion was noticed on the bottom battery.There also appeared to be fluid marks on the mechanism rails.Without further information, it cannot be determined how or when the damages to the device occurred.
|
|
Search Alerts/Recalls
|
|
|