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Model Number MS9662
Device Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problems Hyperglycemia (1905); Underdose (2542); No Code Available (3191)
Event Date 10/31/2019
Event Type  Injury  
Manufacturer Narrative
If device is returned, evaluation will be performed to determine if a malfunction has occurred. This is an initial report. A follow-up report will be submitted when the final evaluation is completed.
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), concerned an (b)(6)-year-old (at the time of initial report) female patient of an unknown origin. Medical history included type i diabetes and historical medication included unspecified insulin since 2004. Concomitant medications included levothyroxine sodium and tocopherol for an unknown indication. The patient received insulin lispro (rdna origin) injections (humalog 100u/ml) from cartridge via reusable pens (humapen luxura burgundy and humapen luxura half-dose), subcutaneously, for the treatment of diabetes mellitus, beginning in 2009. Dosage regimen was not provided and was changed according to carbohydrate diet. In 2016, after starting insulin lispro therapy, she had pancreatitis. On (b)(6) 2019, she bought three packages of insulin lispro cartridges. She suffered from drug ineffectiveness (product complaint number (b)(4)/lot number d062140f). In (b)(6) 2019, her blood glucose did not decreased because some of cartridges were ineffective and some were broken. On an unknown date, her blood glucose level increased to 500-600 (units and baseline values not provided). Reportedly, she was applied 22iu of insulin lispro but it was ineffective. They had nine insulin lispro cartridges and aluminum foil of the cartridges were never touched, cartridges plugs were dislocated and fluid was leaking. The events of pancreatitis and blood glucose increased were considered as serious due to their medical significance. Reportedly, on an unknown date, the black piston in the humapen luxura half-dose pen was broken (pc number (b)(4)/ lot number 1411g06) and two humapen luxura burgundy devices had pressing difficulty (pc (b)(4) / lot number 1206b01) (pc (b)(4)/ lot number 1203b01). Information regarding corrective treatments, outcome for the events and insulin lispro treatment status was unknown. The mother of the patient was the operator of the humapen luxura burgundy devices and the humapen luxura half-dose device and her training status was not provided. The humapen luxura burgundy devices and the humapen luxura half-dose device model duration of use were not provided. For both the humapen luxura burgundy device and the humapen luxura half-dose the device general model duration of use was not provided, but both suspect devices humapen luxura burgundy lot number 1206b01, 1203b01 and humapen luxura half-dose device lot 1411g06 were started more than two years from the time of initial report. The suspect devices humapen luxura burgundy lot number 1206b01, 1203b01 and humapen luxura half-dose device lot 1411g06 were returned to the manufacturer on an unspecified date. The reporting consumer did not provide an opinion of relatedness of events with insulin lispro treatment or the humapen luxura burgundy and humapen luxura half-dose devices. Update 02-dec-2019: information received on 25-nov-2019 and 26-nov-2019 were processed together. Update 10dec2019: additional information received on 09dec2019 from global product complaint database. Recoded the suspect humapen luxura hd (model ms9673) to a humapen luxura hd (model ms9673a). Updated the lot number from unknown to 1411g06 for product complaint (b)(4) relating to the humapen luxura hd device. Recoded humapen luxura, unknown pen body type to humapen luxura burgundy. Updated the lot number from unknown to 1206b01 for product complaint (b)(4) relating to the humapen luxura burgundy device. Corresponding fields and narrative updated accordingly. Edit 12-dec-2019: upon review of the case, operator of the device was updated to mother from other (unknown) and training status of the operator was added in the narrative. No other changes were made to the case. Edit 12dec2019: updated medwatch fields for expedited device reporting. No new information added. Update 12-dec-2019: additional information received on 09-dec-2019 via responsible complaint person (rcp). Suspect products were returned to the manufacturer. Suspect products insulin lispro cartridge with lot number d062140f, humapen luxura hd with lot number 1411g06 and humapen luxura with lot number 1206b01 were confirmed. A new humapen luxura lot number 1203b01 was also returned, reported and considered as suspect. A new suspect humapen luxura burgundy with batch number 1203b01 was added to the case. Pc (b)(4) was provided, processed and added to the narrative. Corresponding fields and narrative updated accordingly.
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Manufacturer (Section D)
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
medical device manufacturing
415 red cedar street
menomonie WI 54751
Manufacturer Contact
chris davis
lilly corporate center
indianapolis, IN 46285
MDR Report Key9511488
MDR Text Key189049748
Report Number1819470-2019-00221
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 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMS9662
Device Lot Number1206B01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2012
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: 12/23/2019 Patient Sequence Number: 1