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

Model Number MS9557

Device Problems Device Inoperable (1663); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 nurse reported on behalf of a male patient that the dose knob of his humapen ergo ii device could not be rotated.He experienced abnormal blood glucose.The device was not returned for investigation (batch unknown).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.All humapen ergo ii devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality with high probability.There is no evidence of improper use.

Event Description

(b)(4).This spontaneous case, reported by nurse, to report adverse event and product complaint concerned an (b)(6) male patient of (b)(6).Medical history included hypertension, and concomitant medications were not provided.The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) injections (humalog 25, 100 units/ml cartridge) via reusable pen humapen ergo ii, 18 units in morning , 8 units in afternoon and 8 units in evening, subcutaneously for the treatment of diabetes mellitus beginning from unspecified date.On an unspecified date after starting insulin lispro protamine suspension 75%/insulin lispro 25%, he did not injected the injection because of the breakdown of injection from the end of (b)(6) 2018 ((b)(4); batch number unknown).On (b)(6) 2018, he was hospitalized because blood glucose was not controlled good (lab value was not provided) and hospitalization discharge dates were not provided.Information regarding corrective treatment and outcome of events was not provided.Insulin lispro protamine suspension 75%/insulin lispro 25% therapy status was continued.The user of the humapen ergo ii was patient and his training status was not provided.The humapen ergo ii model duration of use and suspect device duration of use was not reported.The action taken with the suspect device was not provided and its return was not expected.The reporting nurse did not know about relatedness assessment between the events and insulin lispro protamine suspension 75%/insulin lispro 25% treatment and did not provide with humapen ergo ii.Edit 25apr2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting.No new information added.Update 14may2018: additional information received on 14may2018 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.Noted the humapen ergo ii device associated with (b)(4) was not returned to the manufacturer.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: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 7518102
• MDR Text Key: 108382854
• Report Number: 1819470-2018-00074
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MS9557
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 66