MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II; FOR TREATMENT PURPOSES

Model Number MS9557

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 09/30/2013

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.(b)(4).No further follow up is planned.Evaluation summary: a male patient reported the injection screw on his humapen ergo ii device "could not move out." he experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch 1109d03, manufactured september 2011).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of the batch did not identify any atypical trends with regard to injection screw/ratchet not moving or dose accuracy.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, which would detect a non-moving injection screw and ensure dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case, reporter by a consumer via a patient support program (psp), concerns a (b)(6) asian male patient.Medical history was not provided.Concomitant medications included metformin and acarbose for unknown indications.The patient received human insulin (rdna origin) 30% regular/70% nph (humulin 70/30) cartridge, via humapen ergo ii, 12 units in the morning and 18 units in the night for the treatment of diabetes mellitus, beginning in (b)(6) 2012.In (b)(6) 2013 he was hospitalized since his blood glucose level could not decrease, his postprandial blood glucose (ppbg) two hours after meal was 17 (no units provided).In the hospital his dose was changed to 22 units in the morning and 26 units at night under his physician prescription.On (b)(6) 2015 he was hospitalized once again due to an increase in his body weight of 5 kg and his fasting blood glucose (fbg) was between 12-15 and ppbg was 25 (no units provided).During hospitalization patient was administered human insulin (rdna origin) 30% regular/70% nph via pump (details not provided).On (b)(6) 2015 his human insulin (rdna origin) 30% regular/70% nph dose was changed to 30 units in the morning and 30 units at night.And his blood glucose was already under control and was recovering from the rest of the events.On (b)(6) 2015 humapen ergo had a problem (pc 3502260, lot number 1109d03).On (b)(6) 2015, the patient was planning to be discharged from the hospital.It was unknown if human insulin (rdna origin) 30% regular/70% nph was continued.The user of the device and its training status was not reported.The device model duration of use and suspect device duration of use was not provided but started since (b)6) 2012.The device was not returned.The reporting consumer did not know if there was a relation between human insulin (rdna origin) 30% regular/70% nph or humapen ergo ii and the reported events.Edit 02-dec-2015: sentence of humapen had a problem was removed from narrative since pc was rejected for pc only.Edit 14-jan-2016: pc was reprocessed, accepted and added to narrative.Update 29-feb-2016: additional information received on 29-feb-2016 from the global product complaint database added the device specific safety summary and manufactured date of the device; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.

• Brand Name: HUMAPEN ERGO II
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; 415 red cedar street; medical device manufacturing; menomonie WI 54751
• Manufacturer Contact: caroline rosewell ; lilly corporate center; indianapolis, IN 46285 ; 3172764376
• MDR Report Key: 5494531
• MDR Text Key: 40130323
• Report Number: 1819470-2016-00047
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K151686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1109D03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACARBOSE
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 78