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

Model Number MS9557

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Vomiting (2144)

Event Date 03/19/2017

Event Type  Injury  

Manufacturer Narrative

Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem.No further follow up is planned.Evaluation summary a consumer reported on behalf of a female patient that the injection screw of her humapen ergo ii device was not working.The patient experienced increased blood glucose levels.The device was not returned to the manufacturer for investigation (batch number 1206d02, manufactured june 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review of this batch did not identify any atypical findings with regard to device not working or not accurate.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability there is no evidence of improper use or storage.

Event Description

(b)(4).This solicited case reported by a consumer via a patient support program (psp), with additional information from the initial reporter via a psp, with additional information from the initial reporter, concerned a (b)(6) (at the time of initial report) female patient of unknown origin.Medical history included diabetes since 2010, using several insulins such as insulin human injection/isophane, insulin detemir, insulin human and insulin glulisine.Sometimes her blood glucose was raised when she had a common cold or was stressed from exams, however, it never exceed 200 (no units or reference ranges provided).Also she was not monitoring her diet.Concomitant medications included insulin glargine for the treatment of diabetes mellitus.The patient received insulin lispro (rdna origin) injections (humalog 100 u/ml) cartridge, via reusable pen (humapen ergo ii) 7 iu before breakfast, 10 iu before lunch and 7i u before dinner, subcutaneously, for the treatment of diabetes mellitus, beginning on (b)(6) 2017.From (b)(6) 2017, her blood sugar was very high (the values were unavailable due to her device was not showing the numbers) and that the injection screw of her humapen ergo ii device was reportedly not working ((b)(4) / lot number 1206d02).On (b)(6) 2017, she experienced colic and vomiting, so she was taken to the hospital where her doctor measured her blood sugar and it was 625 (units not provided); also made an acetone test that resulted positive (+3) no reference ranges provided, so she was admitted to the intensive care unit (icu) and was diagnosed with hyperglycemia.She was treated with unspecified intravenous solutions, unspecified antibiotics and with unspecified act rapid insulin.On this same date, insulin lispro treatment was stopped for an unspecified reason.Once her blood glucose was checked for several times and reached 114 and 109 (no units or reference ranges provided), she was released from the hospital after one day, but she was then transferred to the endocrinology department for a week, being discharged sometime in (b)(6) 2017.She was recovering from hyperglycemia.Information regarding outcome of the remaining events and insulin lispro status after its discontinuation was not provided.The user of the humapen ergo ii and its training status was not provided.The general model duration of use and the suspect model duration of use were not provided.The humapen ergo ii was not returned to the manufacturer.The reporting consumer assessed the events as not related to insulin lispro and related the events to the fact that patient recently changed her medication.The reporting consumer did not provide an assessment of relatedness between the events and the humapen ergo device.Update 29-jun-2017: this case was determined to be non-valid as it was reported a hospitalization as an event only.Update 07-jul-2017: this case was initially determined to be non-valid (hospitalization described only).Additional information was received on 02-jul-2017 from the initial reporter via a psp which contained valid adverse event information.Added the serious events of blood glucose increased, blood ketone body present, abdominal pain, vomiting and the non-serious event of blood glucose increased.Humapen ergo ii device was changed to suspect.Added lab data.Narrative was added including the new information.Update 17jul2017: updated medwatch fields for expedited device reporting.Update 19-jul-2017: additional information received on 15-jul-2017 from the initial reporter.Added medical history of diabetes, cold, blood glucose increased and three new historical drugs except insulin glulisine, lab data of acetone and blood glucose increased, hospital discharge date.Updated coding term and outcome for event of her blood sugar was 625 from blood glucose increased to hyperglycemia, from unknown to recovering, treatment for hyperglycemia and acetone from unknown to yes and narrative with new information provided.Update 24jul2017: additional information received on 19jul2017 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields with device information and the european and canadian (eu/ca) device information.Added date of manufacturer and lot number 1206d02 for the humapen ergo ii suspect device.Corresponding fields and narrative updated accordingly.

• 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: 6751529
• MDR Text Key: 81314135
• Report Number: 1819470-2017-00126
• 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: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MS9557
• Device Lot Number: 1206D02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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: INSULIN LISPRO; LANTUS
• Patient Outcome(s): Hospitalization
• Patient Age: 12 YR