http://www.yourlawyer.com/topics/overview/disetronic_h-tron_insulin_pump Sat, 21 Nov 2009 22:22:43 -0800 pixel-app en http://www.yourlawyer.com/articles/read/10407 Wed, 08 Oct 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10407 a) Disetronic H-TRON V100 Insulin Pump, catalog # 8010030C
(clear case) and 8010030 (solid-color case).
Recall # Z-1196-03;
b) Disetronic H-TRONplus Insulin Pump, catalog # 8050023
(clear case), 8050064 (blue case), 8050021 (solid-
color case) and 8050071 (yellow case).

Recall # Z-1197-0.

CODE: All units.

RECALLING FIRM/MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated July 16, 2003. FDA initiated recall is ongoing.

REASON: Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

VOLUME OF PRODUCT IN COMMERCE: 2,082.

DISTRIBUTION: Nationwide.]]> http://www.yourlawyer.com/topics/overview/disetronic_h-tron_insulin_pump Wed, 08 Oct 2003 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/disetronic_h-tron_insulin_pump Disetronic H-Tron Insulin Pump The Disetronic H-Tron Insulin Pumps have been linked to Hypoglycemia and Hyperglycemia. In July 2003 Disetronic announced it would stop selling its H-Tron v100 and H-Tron plus v100 insulin pumps, after the FDA found safety violations at the company's manufacturing facility. The FDA found several problems with these insulin pumps including: water ingress, cracks in the case, and short lived batteries.

H-Tron insulin pumps that have any of these defects can lead to water entering the pump which can result in the unintended delivery of a bolus, which can cause severe health complications including hyperglycemic and hypoglycemic effects. Symptoms of Hypoglycemia include: dizziness, shakiness, sweating, hunger, seizure, headache, confusion, moodiness and crying. Symptoms of Hyperglycemia include: frequent urination, high blood sugar, high levels of sugar in urine and increased thirst.

If you or a loved one suffered injuries from a Disetronic H-Tron insulin pump, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>