Device product
VariSoft infusion set, Model Number 1002828
Z-0233-2024
Product summary
- Firm
- Unomedical A/S
- Event
- Event 93269
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1679 units
- Official record key
device-enforcement:Z-0233-2024
Official wording
Reason: The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis.
Code information: GTIN 05705244018730, Serial Numbers: 5388367, 5388376; GTIN 05705244018723, Serial Numbers: 5388367. 5388376
Distribution pattern: US Nationwide distribution in the state of CA.
Derived failure modes
-
Unknown
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.hyperglycemia). Diabetic ketoacidosis.