MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problems Crack (1135); Fracture (1260)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Manufacturer Narrative

If device is returned, evaluation will be performed to determine if a malfunction has occurred.This is an initial report.A follow-up report will be submitted when the final evaluation is completed.

Event Description

Lilly case id:(b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a (b)(6) female patient of unspecified origin.Medical history was not provided.Concomitant medications included candesartan and diltiazem both for blood pressure and levothyroxine for thyroid disorder.The patient received insulin lispro (rdna origin) injections (humalog) from a cartridge via reusable pen ( humapen luxura half-dose pen), 10 to 12 units per day via subcutaneous route for diabetes, beginning on an unknown date in 2011.Since an unknown date, after starting insulin lispro therapy, she experienced breast cancer and due to which since (b)(6)2021 she was undergoing chemotherapy and five days before receiving the treatment, she received a shot of unspecified steroids and during those five days, her blood glucose were very high (values, units and reference range were not provided).Due to high blood sugar while receiving chemotherapy she was hospitalized.Additionally it was reported that with humapen something was cracked and not broken off on the black threads on the body of the pen, just below the green body of the pen where the cartridge holder screws onto (pc number (b)(4), lot number 1208g08).Further information regarding corrective treatment was not provided.On (b)(6)2021, her blood glucose was normal and outcome of breast cancer was unknown.Insulin lispro therapy was continued.The operator of the as humapen luxura half-dose pen and his/her training status was not provided.The general as humapen luxura half-dose pen model duration of use and the reported as humapen luxura half-dose pen duration of use was not provided.Action taken with as humapen luxura half-dose pen was not provided and its return status was expected.The reporting consumer did not know relatedness of the events with insulin lispro therapy and as humapen luxura half-dose pen.Edit 02dec2021: updated medwatch and european and (b)(6) fields for expedited device reporting and added udi number.No new information added.

Manufacturer Narrative

B.5.Narrative field: new, updated, and corrected information is referenced within the update statements in b.5.Please refer to update statement (s) dated (b)(6) 2021 in the b.5.Field.No further follow-up is planned.Evaluation summary: a female patient reported that something was cracked and not broken off on the black threads on her humapen luxura hd device just below the green body of the pen where the cartridge holder screws onto the device.The patient experienced increased blood glucose, while at the same time also undergoing steroid therapy.The device was not returned to the manufacturer for investigation (batch 1208g08, manufactured august 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.An overall batch complaint threshold review did not identify any atypical findings.All luxura hd 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 or storage.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This spontaneous case, reported by a consumer who contacted the company to report adverse events and product complaint (pc), concerned a 58-year-old female patient of unspecified origin.Medical history was not provided.Concomitant medications included candesartan and diltiazem both for blood pressure and levothyroxine for thyroid disorder.The patient received insulin lispro (rdna origin) injections (humalog) from a cartridge via reusable pen ( humapen luxura half-dose pen), (b)(4).Units per day via subcutaneous route for diabetes, beginning on an unknown date in 2011.Since an unknown date, after starting insulin lispro therapy, she experienced breast cancer and due to which since (b)(6) 2021 she was undergoing chemotherapy and five days before receiving the treatment, she received a shot of unspecified steroids and during those five days, her blood glucose were very high (values, units and reference range were not provided).Due to high blood sugar while receiving chemotherapy she was hospitalized.Additionally it was reported that with humapen something was cracked and not broken off on the black threads on the body of the pen, just below the green body of the pen where the cartridge holder screws onto (pc number (b)(4), lot number 1208g08).Further information regarding corrective treatment was not provided.On (b)(6) 2021, her blood glucose was normal and outcome of breast cancer was unknown.Insulin lispro therapy was continued.The operator of the as humapen luxura half-dose pen and his/her training status was not provided.The general as humapen luxura half-dose pen model duration of use and the reported as humapen luxura half-dose pen duration of use was not provided.Action taken with as humapen luxura half-dose pen was not provided and it was not returned to manufacturer.The reporting consumer did not know relatedness of the events with insulin lispro therapy and as humapen luxura half-dose pen.Edit 02dec2021: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting and added udi number.No new information added.Update 07dec2021: additional information received on 05dec2021 from the global product complaint database.Entered device specific safety summary (dsss).Updated the medwatch fields/ european and canadian (eu/ca) device information for pc (b)(4) associated with lot number 1208g08 of device humapen luxura half-dose pen; added date of manufacturer.Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• 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; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 12924648
• MDR Text Key: 288831975
• Report Number: 1819470-2021-00163
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00300029673019
• UDI-Public: 00300029673019
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Catalogue Number: MS9673
• Device Lot Number: 1208G08
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2012
• 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: 58 YR
• Patient Sex: Female