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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 Device Inoperable (1663)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Manufacturer Narrative
New updated and corrected information is referenced within the update statements. Please refer to statement dated 17sep2017. No further follow up is planned. This report is associated with 1819470-2017-00154 and 1819470-2017-00156, since there is more than one device implicated. Evaluation summary: a female patient reported her humapen ergo ii device did not click when the injection button was pushed down. In addition, insulin leaked from the needle after it was "pulled out. " the patient experienced abnormal blood glucose. The investigation of the returned device (batch number 0801d05, manufactured january 2008) found that the device met functional requirements and met dose accuracy and glide (injection) force specifications. No malfunction was identified. There is no evidence of improper use or storage.
 
Event Description
Lilly case id: (b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complain (pc), concerned a (b)(6) female patient of unknown origin. Medical history included hypertension. Concomitant medications included, metformin and combination of insulin human with insulin human injection and isophane all used for unknown indications. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix25) via cartridge from a reusable pen (humapen ergo ii), subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in the end of year 2016; initial dose and frequency were not reported. She was also using insulin lispro (rdna origin) (humalog 3ml: 300 iu) ) via cartridge from a reusable pen (humapen ergo ii), 10 units in morning, 10 units in noon, and 10 units in night, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date at the end of year 2016. On an unknown date, while on insulin lispro protamine suspension 75%/insulin lispro 25%, her blood glucose was not controlled well (values and reference range not provided), so she was admitted into the hospital. Her physician changed the insulin lispro protamine suspension 75%/insulin lispro 25% to insulin lispro. On an unknown date, her insulin was not injected due to a humapen ergo ii issue further described as there was no clicking sound when the injection button was pushed down (pc (b)(4) /lot unknown). It was also noted that insulin leaked from the needle after it was pulled out. On an unknown date in (b)(6) or (b)(6) 2017 (specific time was unknown), she failed to inject insulin lispro into her body because of injection pen fault further described as no clicking sound when the injection button was pushed down (pc(b)(4) /lot 0801d05; (b)(4) / 1208d02). Information regarding corrective treatment was not reported. Outcome of the events was reported as unknown. Insulin lispro treatment was continued. The operator of the devices was patient and her training status was not provided. The suspect devices duration of use were not reported. The suspect device with pc (b)(4) was not returned to the manufacturer. The device with pc (b)(4) was returned to the manufacturer on 15aug2017; the suspect device relating to pc (b)(4) was not returned to the manufacturer. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% or insulin lispro and did not provide an opinion of relatedness with humapen ergo ii devices. Update 22aug2017: updated medwatch fields for expedited device reporting. No new information added. Update 05sep2017: additional information received on 05sep2017 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch /european and (b)(6) (eu/ (b)(6)) device information and device return status to not returned to manufacturer for pc (b)(4) associated with humapen ergo ii device. Added date returned to manufacturer for pc (b)(4) associated with humapen ergo ii device. Corresponding fields and narrative updated accordingly. Update 17sep2017: additional information received on 14sep2017 from the global product complaint database. Entered device specific safety summary (dsss); updated the medwatch fields with device information and the european and (b)(6) (eu/(b)(6)) device information for the suspect humapen ergo ii associated with product complaint (b)(4). Entered device specific safety summary (dsss); updated the medwatch fields with device information, the european and (b)(6) (eu/(b)(6)) device information, and malfunction from unknown to no; added date of manufacturer for the suspect humapen ergo ii associated with product complaint (b)(4). 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 1819470-2017-00154 and 1819470-2017-00156, since there is more than one device implicated.
 
Event Description
(b)(4). This spontaneous case, reported by a consumer who contacted the company to report adverse events and a product complain (pc), concerned a (b)(6) female patient of unknown origin. Medical history included hypertension. Concomitant medications included, metformin and combination of insulin human with insulin human injection and isophane all used for unknown indication. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog mix25) via cartridge from a reusable pen (humapen ergo ii), subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in the end of year 2016 initial dose and frequency were not reported. She was also using insulin lispro (rdna origin) (humalog 3 ml: 300 iu) ) via cartridge from a reusable pen (humapen ergo ii), 10 units in morning, 10 units in noon and 10 units in night, subcutaneously for the treatment of diabetes mellitus, beginning on an unknown date in the end of year 2016. On an unknown date while on insulin lispro protamine suspension 75%/insulin lispro 25%, her blood glucose was not controlled well (values and reference range not provided), so she was admitted into the hospital. Her physician changed the insulin lispro protamine suspension 75%/insulin lispro 25% to insulin lispro. On an unknown date in (b)(6) 2017 (specific time was unknown), she failed to inject insulin lispro into her body because of injection pen fault. Information regarding corrective treatment was not reported. Outcome of the events was reported as unknown. Insulin lispro treatment was continued. The operator of the devices was patient and her training status was not provided. The suspect devices humapen ergo ii (lot: unknown), humapen ergo ii (lot: 0801d05 and 1208d02) duration of use was not reported. If device is returned, evaluation will be performed to determine if a malfunction has occurred. The reporting consumer did not know if the events were related to insulin lispro protamine suspension 75%/insulin lispro 25% or insulin lispro and did not provide an opinion of relatedness with humapen ergo ii. Update 22aug2017: updated medwatch fields for expedited device reporting. No new information added.
 
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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 Key6849831
MDR Text Key266781523
Report Number1819470-2017-00155
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 consumer,foreign
Type of Report Initial,Followup
Report Date 10/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS9557
Device Lot Number0801D05
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/15/2017
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2008
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: 09/07/2017 Patient Sequence Number: 1
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