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Model Number UNKNOWN
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Inflammation (1932); Numbness (2415); Coma (2417)
Event Date 01/31/2018
Event Type  Injury  
Manufacturer Narrative
Since the device is not being returned, evaluation for a malfunction is not possible. This is an initial report. A follow-up report will be submitted when the final evaluation is completed. This report is associated with 1819470-2019-00143 since there is more than one device implicated.
Event Description
Lilly case id: (b)(4). This report is associated with product compliant: (b)(4). This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via a psp, concerned a (b)(6) male patient of an unspecified origin. Medical history included a previous use of a humapen savvio on unspecified dates. Concomitant medications included pregabalin, benfotiamine/ cyanocobalamin/ pyridoxine hydrochloride and hydroxocobalamin; all for the treatment of neuropathy. The patient received human insulin isophane suspension 70%/ human insulin 30% (rdna origin) injections (humulin 70/30) suspension via a reusable pen (humapen savvio gray) and (humapen ergo unknown body type), 30 iu before taking breakfast or lunch and at night (twice daily), subcutaneously for the treatment of diabetes beginning approximately before 2009. Approximately, since 2015, he was experiencing numbness in his toes, so was prescribed with pregabalin firstly once daily, and then his dose was increased to twice daily. Approximately, since 2016 he was experiencing inflammation in his palm joints. On an unspecified date, but during 2018 reportedly he was hungry, but did not eat anything and took his insulin dose which lead to a low blood glucose associated with coma (no units or values were provided). The patient took a juice and recovered. This event of blood glucose associated with coma was considered as serious by the company due to its medical significance. On an unspecified date, approximately, since (b)(6) 2019 he was experiencing high blood glucose levels sometimes reaching 270-280 mg/dl (reference values were not provided). On (b)(6) 2019, it was reported that on an unspecified date the screw of the humapen savvio was not working properly and as a consequence the humapen savvio dispensed an extra dose of insulin (pc: (b)(4) /lot: unknown). The humapen saavio and humapen ergo possibly had been used for more than 3 years. Reportedly, some days he did not miss any doses as he was using the humapen ergo of his sister; he did not have his own spare pen, but he was missing doses when he could not go to her. Approximately since (b)(6) 2019, his humapen ergo started to get stuck, heavy and loose sometimes (pc: (b)(4)/ lot: unknown). In (b)(6) 2018 his blood glucose was high at 300 mg/dl (no reference values were provided). On (b)(6) 2019 he fully recovered from the event of missed doses. Information regarding additional corrective treatment was not provided. The outcome of the events of numbness, joint inflammation, and two episodes of high blood glucose levels was not recovered. He recovered from the event of low blood glucose associated with coma. The outcome of the remaining events was not provided. The treatment with human insulin 70/30 was ongoing. The user of the humapen savvio was the patient but his training status was not provided. The general humapen savvio model duration of use was not provided; the humapen savvio model had been used for more than 4 years. The duration of use for the humapen savvio considered as suspect was not provided, but at the time of initial report, it had been used likely for about 3 or 4 years. The general humapen ergo model duration of use was not provided, the suspect humapen ergo duration of use was approximately three years. The suspect humapen savvio was not returned to the manufacturer. The suspect humapen ergo was discarded in (b)(6) 2019; so its return was not expected. The reporting consumer considered the event of low blood glucose associated with coma as related to the treatment with human insulin 70/30 and did not provide any other opinion of causality between remaining events and human insulin 70/30 treatment. The reporting consumer considered the event of extra dose of insulin as related to the humapen savvio, did not provide an opinion of causality between event of hunger and the humapen savvio and considered the events of numbness, arthritis, blood glucose increased and low blood glucose with coma as not related to the humapen savvio. The reporting consumer related the events of drug dose omission and second episode of blood glucose increased to the humapen ergo. No other opinion of causality was provided. Edit 01aug2019: upon review, the reported date for pc (b)(4) associated with the humapen savvio gray device was added to the case. No other changes were made. Update 07aug2019: additional information received on 05aug2019 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information, and device return status to not returned to manufacturer for pc (b)(4) associated to unknown lot of humapen savvio (gray) device. Upon internal review, changed the device age to 4 years. Corresponding fields and narrative updated accordingly. Update 17-sep-2019: additional information received on 10-sep-2019 from the initial reporter via a psp. Added a humapen ergo unknown as suspect device, the new non-serious events of drug dose omission and a second episode of blood glucose increased and laboratory data. Updated dosage regimen of human insulin 70/30 from once daily to twice daily. The narrative was updated with the new information. Edit 25sep2019: updated medwatch fields for expedited device reporting. No new information added. Updated the date of the previous update statement to clarify the month the update statement was written. Edit 30-sep-2019: upon catool reconciliation pc (b)(4) was received, processed and added to the narrative. No changes were made to the case.
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Brand NameHP ERGO
Manufacturer (Section D)
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
medical devices manufacturing
415 red cedar st.
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key9152477
MDR Text Key168021292
Report Number1819470-2019-00180
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2019
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: 10/03/2019 Patient Sequence Number: 1