Disetronic Medical Systems, Inc. Recalls
Showing 1-3 of 3 recalls
Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.
The "up" and "down" buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.
The firm issued a press release on 4/30/09 and sent letters with attached Urgent Medical Device Recall (Field Corrective Action) notification dated 5/4/09 to distributors, health care providers and users. Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the up and/or down button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. For pumps within the affected serial numbers (SN02119552 to SN10006093) which are functioning properly, no replacement is available/possible at this time. Disetronic will gradually phase in replacement pumps for the remaining pumps within the affected range, as they become available. Customers are to complete the enclosed Customer Reply Card to acknowledge receipt of the notification. On 5/17/11, after being notified of the recall's ineffectiveness (in that only 40% of the pumps had been replaced), the firm re-issued recall notification letters including the aforementioned information to their consignees.
Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001.
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
"U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
The battery may turn the pump off without warning due to a design change in the battery.
Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice.