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Model Number MS9698
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
(b)(4). This solicited case reported by a consumer via a patient support program (psp) concerned a (b)(6) (at the time of initial report) mexican female patient. Medical history and concomitant medications were not provided. The patient received insulin lispro protamine suspension 75%/insulin lispro 25% (rdna origin) (humalog 25) from cartridge, via a humapen savvio reusable device, at doses 20 iu at the morning, 16 or 17 iu at the afternoon and 15 iu at night subcutaneously for pancreatitis (off-label use) on an unknown date in (b)(6) 2019. On an unknown date in (b)(6) 2020, while being on the insulin lispro protamine suspension 75%/insulin lispro 25% therapy, she was hospitalized for 10 days (the exact dates were ot provided), she mentioned that she was admitted and discharged with high glucose values. The values was approximately of 200 mg/dl. Humalog mix 25 did not work because the insulin of retarded action ((b)(4), batch: 1305v07) had an efficiency of eight hours and she applied util three times at day, this caused to her insulin resistance to the insulin and high and low blood glucose levels, the highest value was approximately 550 mg/dl, and the lowest value was 30 mg/dl. As corrective action, the treatment with insulin lispro + insulin lispro protamine (humalog mix 25) was changed to fast acting insulin lispro (humalog), this insulin kept her stable after each meal as it stopped the hit of each meal (as reported) together with the basal or insulin degludec (tresiba) that was applied every 24 hours. Humalog was administered for pancreatitis and she applies 6 ui at morning, 8 ui at the meal hour and 7 ui at night, she started this treatment in (b)(6) 2020 and continues. On an unknown date, she purchased by mistake insulin lispro + insulin lispro protamine (humalog mix 25) in cartridge presentation because she did not remember the correct name of the insulin but she did not apply the medication. Information regarding further corrective treatment and outcome for the events was not provided. It was unknown if insulin lispro protamine suspension 75%/insulin lispro 25% was restarted. The operator of humapen savvio and her training status was not provided. The general humapen savvio and suspect humapen savvio duration of use was unknown. The status of humapen savvio was not provided and its return status was not expected. The reporting consumers related the event of lode with insulin lispro protamine suspension 75%/insulin lispro 25% therapy whereas no relatedness was provided for the remaining events. The reporting consumers did not provide any relatedness assessment of the events and the humapen savvio reusable device. Update 25-oct-2021: additional information received from initial reporter via (psp) on 18-oct-2021. Added a suspect device humapen savvio along with its eu(b)(6) fields. Updated the formulation of suspect drug humalog mix25 to cartridge, its corresponding fields, causality statement and the narrative with new information. Update 01-nov-2021: information was received from affiliate on 26-oct-2021 and source document was modified in order to correct the receipt date from 07-oct-2021 to 06-oct-2021. No new medically significant information was reported, hence no changes were made to the case. Update 15-nov-2021: information was received from initial reporter on 09-nov-2021 via psp. All the information received on 09-nov-2021 and cire report were processed together. Patient had the device but it was in use. Hence no changes were made to the case. Update 16nov2021: additional information received on 11nov2021 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, date of manufacturer for lot number 1305v07 associated with (b)(4) of humapen savvio device which was not returned. Corresponding fields and narrative updated accordingly.
Manufacturer Narrative
Narrative field: new, updated, and corrected information is referenced within the update statements in describe event or problem. Please refer to update statement (s) dated (b)(6) 2021 in the describe event or problem. Field. No further follow-up is planned. Evaluation summary: a female patient reported that while using a humapen savvio device she was hospitalized for 10 days in (b)(6) 2020 due to increased blood glucose. No device malfunction was reported, and the patient continued to use the device without further incident as of report date 06-oct-2021. The device was not returned to the manufacturer for investigation (batch 1305v07, manufactured may 2013). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review did not identify any atypical findings with regard to dose accuracy issues. All humapen savvio devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability. There is no evidence of improper use or storage.
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Manufacturer (Section D)
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
415 red cedar street
medical device manufacturing
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key12829323
MDR Text Key282992238
Report Number1819470-2021-00152
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9698
Device Lot Number1305V07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2013
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: 11/17/2021 Patient Sequence Number: 1