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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 Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)
Event Type  Injury  
Manufacturer Narrative
New, updated and corrected information is referenced within the update statements in describe event or problem. Please refer to update statement dated 08mar2017 in describe event or problem. No further follow up is planned. This report is associated with 1819470-2017-00050 and 1819470-2017-00049, since there is more than one device implicated. Evaluation summary: a male patient stated the injection button of his humapen ergo ii could not be pushed down and no insulin was delivered. He experienced increased blood glucose levels (date unknown). The device was not returned to the manufacturer for investigation (batch 1511d03, manufactured november 2015). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. The patient reported he changed needles every three days. Troubleshooting was performed by the patient with guidance from a trained professional. A new cartridge was inserted, a new needle was attached, and priming was performed. The insulin was then released normally. There is evidence of improper use. The patient reused needles which may be relevant to the event of increased blood glucose levels.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unspecified origin. Medical history included that his eyes could not see and hypertension. Concomitant medications included acarbose for an unspecified indication. The patient received human insulin (rdna origin) (unspecified type) subcutaneously via cartridges using an unspecified reusable humapen (reported as lilly pen), two times each day for the treatment of type i diabetes mellitus starting in 1998; dose was not reported. Reportedly he stopped the human insulin in 2010 for unspecified reasons. Since 2010 he received insulin lispro (rdna origin) (humalog 100 u/ml) subcutaneously via cartridges using an unspecified reusable humapen(reported as lilly pen), 16 units each morning and 18 units each evening for the treatment of diabetes mellitus type i. On an unspecified date the humapen injection screw could not be moved out ((b)(4)/lot unknown). The device was discarded, and he began using another unspecified humapen (reported as lilly pen) in 2013. The second unspecified humapen also has an injection screw that could not be moved out on an unreported date ((b)(4)/lot unknown). The device was discarded and he began using a reusable pen humapen ergo ii on (b)(6) 2017. On (b)(6) 2017, he reported that the injection button of the humapen ergo ii could not be pushed down ((b)(4)/lot 1511d03). Reportedly he experienced four cerebral infarctions on unspecified times because his blood glucose was high. Both events were considered serious due to its medical significance. Information regarding corrective treatments and the outcome of the events was not reported. The insulin lispro treatment was continued. The user of the device and his/ her training status was not provided. The general and suspect device duration of use for the unknown humapen associated with (b)(4) was approximately 15 years; device was discarded. The general and suspect device duration of use for the unknown humapen associated with (b)(4) was approximately four years; device was discarded. The general and suspect device duration of use for the humapen ergo ii associated with (b)(4) was 21 days; the device was not returned. The reporting consumer did not know if the events were related to the human insulin or insulin lispro treatments and did not provide an assessment of relatedness regarding to the devices. No follow-up would be requested since the reporter refused to provide more information. Treating physician contact details not provided. Update 28-feb-2017: upon review of the original source information from 2-0feb-2017, this case was opened to add the product complaint numbers and information to the product tabs and narrative; updated the improper use and storage to yes for the unknown humapen associated with (b)(4); updated the medwatch and european and canadian required device reporting elements; added the device durations of use; and updated the narrative. Update 02-mar-2017: information received from the rcp on 01-mar-2017. (b)(4) were provided, they would be processed when there were available. Permission to conduct follow-up was retired from the initial reporter on 01-mar-2017. No new adverse event or product information was received. Update 08-mar-2017: additional information received on 08-mar-2017 from the global product complaint database added the device specific safety summary for all three suspect devices; added the manufactured date for the device associated with (b)(4 and that this device was not returned; updated the improper use and storage to yes for the devices associated with the (b)(4); updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
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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 Key6395121
MDR Text Key69622534
Report Number1819470-2017-00048
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
Report Date 03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1511D03
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2015
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: 03/10/2017 Patient Sequence Number: 1
Treatment
ACARBOSE; GLUCOBAY; HUMULIN REGULAR; INSULIN LISPRO
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