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Model Number MS9662
Device Problems Break (1069); Mechanical Jam (2983)
Patient Problems Facial Nerve Paralysis (1846); Fall (1848); Headache (1880); Hyperglycemia (1905); Hypoglycemia (1912); Unspecified Infection (1930); Pain (1994)
Event Date 03/31/2019
Event Type  Injury  
Manufacturer Narrative
Description of problem or event: new, updated and corrected information is referenced within the update statements. Please refer to update statement dated 23may2019. No further follow-up is planned. Evaluation summary: the daughter of a female patient reported that the patient's humapen luxura was jamming. The patient experienced hypoglycemia. The device was not returned to the manufacturer for investigation (batch 1306b02, manufactured june 2013). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. A complaint history review for the batch did not identify any atypical findings with regard to pen jam or dose accuracy issues. All humapen luxura 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.
Event Description
Lilly case id: (b)(4). This report is associated with product compliant: (b)(4). This spontaneous case, reported by a consumer who contacted the company to ask a product information, with additional information received from initial reporter and a second consumer via patient support program (psp), concerns a female patient of unknown ethnicity and age; born on (b)(6). Medical history included surgery for removal of kidney stones, two bypass surgeries, unspecified kidney problems due to many unspecified medicines that was used after the heart surgery, diabetes mellitus and weight loss. Concomitant medications: furosemide, digoxin, amlodipine besilate, ticlopidine hydrochloride, omeprazole, calcium citrate malate+cholecalciferol, pioglitazone hydrochloride, levothyroxine sodium, ayurvedic preparation, ciprofibrate, folic acid, cyanocobalamin, pyridoxine hydrochloride, vitis vinifera seed, rosuvastatin, ezetimibe, fenofibrate and zolpidem tartrate. The patient received human insulin (rdna origin) nph (humulin n) unknown formulation, and human insulin (rdna origin) regular (humulin r) vial, both unknown dose, frequency and route of administration, for treatment of diabetes mellitus beginning in 2012. Since 2013, patient was using a humapen luxura burgundy, however, it was unclear which drugs were delivered by. On an unknown date, reported as in the beginning of treatment with the both human insulin, patient experienced facial paralysis and ear infection. It was reported that according to patients physician, the facial paralysis was due to an unspecified viral infection. In 2013, patient underwent a surgery and six pins were placed on her column due to unknown reasons, and because of this, the patient started presenting leg pain, and sometimes, she needed to be taken to the hospital. Additionally, patient was not seeing right and in (b)(6) 2018, patient underwent an eye surgery where it was placed lens on both eyes. In (b)(6) 2019, approximately six years after starting using humapen luxura burgundy, patient presented high glycemia at 372 (units and normal range not provided). In (b)(6) 2019 patient started presenting headache and experienced a new facial paralysis. Due to the facial paralysis, patient was receiving cortisone and an unspecified shock therapy and recovered on an unknown date. On (b)(6) 2019, the patients glycemia was at 323. 9. On (b)(6) 2019 patients blood glucose was high, however, the glycemia value was not reported. According to patients physician, the blood glucose was not decreasing because she had a lot of cortisone in her body, and patient started presenting hyperglycemia. On an unspecified date, humapen luxura burgundy started jamming, skipping, was not holding the insulin inside and then broke (product complaint (b)(4), batch 1306b02). On an unknown date, patients physician asked the patient to perform an unspecified exam, human insulin nph was discontinued and replaced by insulin glargine (basaglar) via kwikpen, unknown dosage regimen, frequency and route of administration for treatment of diabetes beginning in an undisclosed date in (b)(6) 2019 (conflicting information once it was reported that insulin glargine was not being used when patient had the blood glucose increased on (b)(6) 2019 and (b)(6) 2019). On an unspecified date, unknown time after starting insulin glargine treatment, patient presented blood glucose at 360 and at 490 and felt unwell. Moreover, it was reported that on an undisclosed date in 2019 , patient was experiencing hypoglycemia, and her blood glucose was at 65 and 72. In one of the hypoglycemia episodes, the patient fainted and fell head down. The company considered hypoglycemia, faint, fall and head injury as serious due to medically significant reasons. In addition, it was reported that the insulin applications burned. Patient also used metformin (unknown manufacture), unknown dosage regimen, frequency, route of administration and start date, for unknown treatment, during two years, and also used unspecified antibiotics, which affected her kidney. As of (b)(6) 2019, reporter consumer stated that patient went from (b)(6) to (b)(6). It was unclear if the events of hypoglycemia, injection site burning, weight decreased and kidney disorder occurred when patient was using human insulin nph with human insulin regular, or when patient was using human insulin regular with insulin glargine. No other outcomes were provided. On (b)(6) 2019, it was reported that patient s blood pressure was good, it was 13/8 (unit not provided). The human insulin regular and insulin glargine therapies were continued. Patients daughter was who operated the humapen luxura burgundy and insulin glargine kwikpen, but it was unknown if she was trained. The duration of use for humapen luxura burgundy model was not provided and the duration for use for humapen luxura burgundy lot 1306b02 was approximately six years. The patient had used the reported insulin glargine kwikpen model since (b)(6) 2019 (unclear information) and the duration for use of insulin glargine kwikpen unknown lot was unknown. The humapen luxura burgundy associated with product complaint (b)(4) was not returned to the manufacturer. The insulin glargine kwikpen would not be returned since there was no product complaint for it. The initial and second reporter consumers did not provide a relatedness opinion for hypoglycemia , fell head down, fainted, weight decreased, kidney disorder, application burns and incorrect storage. The initial reporting consumer did not related the events facial paralyses, ear infection, visual impairment, viral infection, hyperglycemia, insomnia, leg pain and headache to human insulin nph and human insulin regular and related the kidney disorder to metformin. Update 15may2019: additional information received on (b)(6) 2019 from initial reporter and a second reporter consumer via psp. Added serious events of hypoglycemia, fainted and fell head down. Added: psp as and a second consumer as reporters, patients address and date of birth; added weight loss as medical history; added metformin, insulin glargine and insulin glargine kwikpen as suspect products; added the non-serious events: kidney disorder, weight loss, hypoglycemia, incorrect storage and application burns; updated event of blood glucose increased to hyperglycemia. Updated narrative and correspondent fields accordingly. Upon internal review, added non-serious event of headache and changed humapen luxura burgundy from concomitant into suspect. Update 17may2019: additional information received on (b)(6) 2019 from initial consumer reporter via psp. Added blood pressure value of day (b)(6) 2019. Update 20may2019: additional information received on (b)(6) 2019 from initial consumer. Added information regarding patients treating physician contact information. No other change was made to the case. Edit 21may2019: updated medwatch and european and (b)(4) (eu/(b)(4)) fields for expedited device reporting. No new information added. Update 23may2019: additional information received on (b)(6) 2019 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information, the european and (b)(4) (eu/(b)(4)) device information, and improper use and storage from yes to no. Added date of manufacturer for the suspect humapen luxura burgundy device associated with product complaint (b)(4), which was not returned to the manufacturer. Corresponding fields and narrative updated accordingly. Edit 29may2019: upon internal review, the case was unlocked in order to correct as reported and as determined causality of fall event for humapen luxura burgundy and insulin glargine kwikpen.
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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 Key8667018
MDR Text Key147059887
Report Number1819470-2019-00103
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
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9662
Device Lot Number1306B02
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2013
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: 06/04/2019 Patient Sequence Number: 1