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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 Component Missing (2306)
Patient Problems Stroke/CVA (1770); Infarction, Cerebral (1771)
Event Type  malfunction  
Manufacturer Narrative
Reportable malfunction/incident identified. Investigation in progress. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unknown ethnicity. Medical history was not reported. Concomitant medications included acarbose and metformin hydrochloride, both for unknown indications. The patient received human insulin (rdna origin) (humulin), from a cartridge, 22 units each morning and 24 units each evening, subcutaneously, for the treatment of diabetes, beginning in 2006 or 2007 (conflicting information provided). On an unknown date, while being on human insulin, he experienced a cerebral infarction and stroke caused by diabetes, for which he was hospitalized on 21-may-2015. On 30-may-2016, he was discharged, after being 10 days hospitalized. Further information regarding hospitalization, including laboratory test findings was not provided. After discharge, his dose was changed to 18 units each morning and 16 units each evening. Then, on an unspecified date, he was hospitalized again for two weeks. Information regarding hospitalization, including dates and laboratory test findings was not provided. On an unspecified date, a physician identified him as level three disability (reason unknown). On an unspecified date, half of his body was uncomfortable and his legs could not be put up. Information regarding corrective treatment and outcome of the events was not provided. Human insulin treatment was ongoing. The patient was the user of the device. Training status was not provided. General and suspect device duration of use was nine years since 2007. The device was returned on 02-sep-2016, and was find to have missing clicks ((b)(4)/ lot 1203d03). The reporting consumer did not know if the events were related to human insulin treatment. Update 12-sep-2016: additional information received on 24-aug-2016. (b)(4) provided. Edit 13-sep-2016: upon review amended suspect product formulation from unknown to cartridge, re-arrange concomitant device and updated narrative accordingly. Update 14-sep-2016: additional information received on 02-sep-2016 from the global product complaint database updated the lot number from unknown to 1203d03; updated the malfunction field to yes/cirm which updated the device to suspect for (b)(4); updated the improper use and storage to yes; added a new non serious event of no adverse effect to associate with the suspect device for device causality; updated the medwatch and european and canadian required device reporting elements; and updated the narrative.
 
Manufacturer Narrative
Narrative field; new updated and corrected information is referenced within the update statements in describe event or problem. Please refer to statement dated 11oct2016 in the describe event or problem field. Evaluation summary a male patient reported that the cartridge holder on his humapen ergo ii device was broken and the dose knob separated from the body of the device. Investigation of the returned device (batch (b)(4), manufactured march 2012) found the cartridge holder appeared normal. The investigation did find that the expected clicks were not heard, there was damage to the dialing screw threads and damage to other internal components. The dial had also been detached from the dialing screw. The investigation determined that the damage was caused by excessive force applied to the device while in the field (not related to manufacturing). Therefore, the reportable malfunction of clicker issues was not confirmed. The user manual provides the proper instructions for use and care of the device. The patient reported using the device for nine years. The user manual states the device was designed to be used for up to 3 years after first use. There is evidence of improper use or storage. The patient used the device beyond its approved use life, although it is unknown if the extended use of the device was relevant to the patient's complaints.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) male patient of unknown ethnicity. Medical history was not reported. Concomitant medications included acarbose and metformin hydrochloride, both for unknown indications. The patient received human insulin (rdna origin) (humulin), from a cartridge, 22 units each morning and 24 units each evening, subcutaneously, for the treatment of diabetes, beginning in 2006 or 2007 (conflicting information provided). On an unknown date, while being on human insulin, he experienced a cerebral infarction and stroke caused by diabetes, for which he was hospitalized on (b)(6) 2015. On (b)(6) 2016, he was discharged, after being 10 days hospitalized. Further information regarding hospitalization, including laboratory test findings was not provided. After discharge, his dose was changed to 18 units each morning and 16 units each evening. Then, on an unspecified date, he was hospitalized again for two weeks. Information regarding hospitalization, including dates and laboratory test findings was not provided. On an unspecified date, a physician identified him as level three disability (reason unknown). On an unspecified date, half of his body was uncomfortable and his legs could not be put up. Information regarding corrective treatment and outcome of the events was not provided. Human insulin treatment was ongoing. The patient was the user of the device. Training status was not provided. General device duration of use was 9 years. Suspect device duration of use was four years since 2012. The device was returned on 02-sep-2016, and was found to have missing clicks, dialing screw and internal damage caused by excessive force in the field((b)(4)/ lot 1203d03). The reporting consumer did not know if the events were related to human insulin treatment. Update 12-sep-2016: additional information received on 24-aug-2016. (b)(4) provided. Edit 13-sep-2016: upon review amended suspect product formulation from unknown to cartridge, re-arrange concomitant device and updated narrative accordingly. Update 14-sep-2016: additional information received on 02-sep-2016 from the global product complaint database updated the lot number from unknown to 1203d03; updated the malfunction field to yes/cirm which updated the device to suspect for (b)(4); updated the improper use and storage to yes; added a new non serious event of no adverse effect to associate with the suspect device for device causality; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update 29sep2016. Information received 28sep2016 from the product complaint safety database did not contain any new information. Update 11oct2016. Additional information received 11oct2016 from the product complaint safety database. To the device tab added the manufacture date, changed the approximate device age to 4 years, changed the malfunction type to not cirm, added the device specific safety summary (dsss), updated the european and canadian (eu/ca) device information, entered the device medwatch information, and the narrative was updated accordingly.
 
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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 Key5973490
MDR Text Key55891694
Report Number1819470-2016-00251
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 08/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9557
Device Lot Number1203D03
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/02/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2012
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: 09/23/2016 Patient Sequence Number: 1
Treatment
GLUCOBAY; INSULIN HUMAN; MELBIN
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