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U.S. Department of Health and Human Services

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

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 01/31/2015
Event Type  Injury  
Manufacturer Narrative
This report is associated with 1819470-2017-00122 and 1819470-2017-00123 since there is more than one device implicated. No further follow-up is planned. Evaluation summary: a male patient reported that the injection button of his humapen (unspecified device) was difficult to push after two years of use. He experienced blood glucose fluctuations. The device was not returned to the manufacturer for investigation (batch unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. All humapen devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring dose accuracy and device functionality with a high probability. There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(4). This solicited case, reported by a consumer, via a patient support program, concerned a (b)(6) year old male patient of (b)(6) origin. Medical history was not reported. Concomitant medication included insulin glargine for diabetes. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30) 3ml:300iu/cartridge (batch unknown/ expiration unknown), daily subcutaneously (dose unknown), via two unknown reusable devices (blue, plastic), clarified as humapen ergo ii pens, beginning on an unspecified date in 2012 for diabetes. It was noted that the injection buttons were difficult to push down after using two years; the specific dates were not provided (pc 4014328 and 4014329/lot numbers unknown). On an unspecified date in 2015 the patient experienced unstable blood sugar and was hospitalized. No further details about the event, treatment or outcome were reported. On an unspecified date in 2015, under the advice of the resident physician the patient discontinued use of human insulin isophane suspension 70%/ human insulin 30% (rdna origin). The patient initiated therapy with insulin lispro (humalog (rdna origin) : 3ml:300iu/cartridge (batch c634239/expiration 31mar2019) and human insulin (rdna origin) (humulin r) : 3ml:300iu/cartridge (batch c595801a/expiration 31mar2018), daily subcutaneously, with dose unknown (adjusted by patient), via unknown reusable device further described as green, metal. It was noted that the metal ring was broken on the green metal device on an unspecified date (pc 4014330/lot unknown). Therapy with insulin lispro and human insulin was ongoing and not identified as being associated with the serious blood sugar event. It was reported that patients blood sugar was unstable and the fluctuation was big. Event outcomes, treatment and hospitalization discharge date were not reported. This case was considered serious due to hospitalization. Training status of the consumer user was not provided. Two humapen ergo ii devices were initiated on an unspecified dates in 2012 and used until an unspecified date for approximately two years to administer human insulin isophane suspension 70%/ human insulin 30%. Unknown reusable device (green, metal) was from unknown lot number batch, was initiated on an unspecified date in 2015 and use was ongoing to administer insulin lispro and human insulin. The two humpen ergo ii devices were not returned to manufacturer; other device return status was not expected. The reporting consumer did not know if the events were related to any of the insulin products. Update 28jun2017: upon review on 28jun2017 of information received on 01jun2017 it was determined that devices used were of unknown type, devices recoded to reflect unknown type. Narrative and corresponding fields updated accordingly. Edit 28jun2017. Medwatch device fields entered for device mailing. No new information. Update 30jun2017. Additional information received 30jun2017 from the product complaint safety database. On the first device tab entered the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, and the narrative was updated accordingly. Update 06jul2017: additional information received on 06jul2017 from the global product complaint database. Recoded devices from unknown to humapen ergo ii, entered device specific safety summary (dsss) and updated medwatch fields and the (b)(4) device information for the devices associated with pc 4014328 and 4014329. Corresponding fields and narrative updated accordingly.
 
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A report will be submitted when the final evaluation has been completed. This report is associated with 1819470-2017-00122 and 1819470-2017-00123 since there is more than one device implicated.
 
Event Description
(b)(4). This solicited case, reported by a consumer, via a patient support program, concerned a (b)(6) male patient of han origin. Medical history was not reported. Concomitant medication included insulin glargine for diabetes. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) (humulin 70/30) 3 ml:300 iu/cartridge (batch unknown/ expiration unknown), daily subcutaneously (dose unknown), via two unknown reusable devices (blue, plastic), beginning on an unspecified date in 2012 for diabetes. On an unspecified date in 2015 the patient experienced unstable blood sugar and was hospitalized. No further details about the event, treatment or outcome were reported. On an unspecified date in 2015, under the advice of the resident physician the patient discontinued use of human insulin isophane suspension 70%/ human insulin 30% (rdna origin). The patient initiated therapy with insulin lispro (humalog (rdna origin) : 3 ml:300 iu/cartridge (batch c634239/expiration 31mar2019) and human insulin (rdna origin) (humulin r) : 3 ml:300 iu/cartridge (batch c595801a/expiration 31mar2018), daily subcutaneously, with dose unknown(adjusted by patient), via unknown reusable device, (green, metal). Therapy with insulin lispro and human insulin was ongoing and not identified as being associated with the serious blood sugar event. It was reported that patients blood sugar was unstable and the fluctuation was big. Event outcomes, treatment and hospitalization discharge date were not reported. This case was considered serious due to hospitalization. Training status of the consumer user was not provided. Two unknown reusable devices (blue, plastic), batch and expiration date unknown for each, were initiated on an unspecified dates in 2012 and used until an unspecified date to administer human insulin isophane suspension 70%/ human insulin 30%. Unknown reusable device (green, metal) was from unknown lot number batch and expiration date unknown, was initiated on an unspecified date in 2015 and use is ongoing to administer insulin lispro and human insulin. It was not reported if reusable devices were being returned. The reporting consumer did not know if the events were related to any of the insulin products. Update 28jun2017: upon review on 28jun2017 of information received on 01jun2017 it was determined that devices used were of unknown type, devices recoded to reflect unknown type. Narrative and corresponding fields updated accordingly. Edit 28jun2017. Medwatch device fields entered for device mailing. No new information.
 
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Brand NameHUMAPEN ERGO II
Type of DeviceFOR 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 Key6676967
MDR Text Key206483083
Report Number1819470-2017-00121
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 08/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9557
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2017
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 Treatment Data
Date Received: 06/29/2017 Patient Sequence Number: 1
Treatment
HUMALOG LISPRO (CARTRIDGE); HUMULIN REGULAR; INSULIN GLARGINE; INSULIN HUMAN
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