This device case, reported by a non-health care professional, concerns a pt.
The pt was using a pen injection device (humapen ergo-burgundy/clear cartridge holder/model ms8930) to deliver insulin for the treatment of diabetes.
The pt had been using the humapen ergo for approx three years.
Prior to complaint device the pt had used humapen ergo (opaque cartridge holder).
The pt rec'd two pen injection devices (humapen ergo-burgundy/clear cartridge holder/model ms8930) directly from the mfr.
The rptr returned the pen injection device with the complaint: the pt had a new pen with burgundy-clear cartridge holderand when putting a new cartridge in, the screw did not go back.
The lead screw was in contact with the bung in the cartridge, but no insulin was coming out.
No adverse drug event is associated with the complaint.
The mfr rec'd the complaint device on mar-2002.
Initial examination revealed the general condition of the pen was good.
No defects were observed.
Final examination of the complaint device by product delivery systems on apr-2002 revealed the two engagement tabs on the clear cartridge holder had been intentionally removed.
Further info rec'd from the initial rptr revealed the pt had not taken the pen apart or removed any part of the pen prior to its return.
The reporter stated that nothing appeared to be missing from the pen prior to returning the device for investigation.
Update apr-2002: corrections made to case.
Initial analysis by pds corrected to apr-2002.
|
