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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO, TEAL/CLEAR FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO, TEAL/CLEAR FOR TREATMENT PURPOSES Back to Search Results
Model Number MS8929
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Cardiac Arrest (1762); Cataract (1766); Chest Pain (1776); Gastritis (1874); Hearing Loss (1882); Hepatitis (1897); Hyperglycemia (1905); Hypoglycemia (1912); Muscle Weakness (1967); Myocardial Infarction (1969); Necrosis (1971); Renal Failure (2041); Retinal Detachment (2047); Loss of Vision (2139); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Convulsion, Clonic (2222); Coma (2417); Weight Changes (2607); No Code Available (3191)
Event Date 04/16/2014
Event Type  Injury  
Manufacturer Narrative
No further follow up is planned. Evaluation summary: the mother of a female patient reported the cartridge holder of her daughter's humapen ergo device was loose. She was unsure if the patient was getting the correct dose. The patient experienced diabetic ketoacidosis. Investigation of the returned device (batch 0404a03, manufactured april 2004) found that the device met dose accuracy and glide (injection) force specifications. No malfunction was identified. The investigation also found one spring arm cracked. This can lead to the perception that the cartridge holder is loose. However, this does not affect the dose accuracy of the device. The patient started using the device in 2005. The user manual states the humapen ergo has been designed to be used for up to 3 years after first use. The user manual also states if any of the parts of your humapen ergo appear broken or damaged, do not use. There is evidence of improper use. The patient used the device beyond the approved use life. The extended use is not relevant to this case as the device met dose accuracy and glide(injection) force specifications. In addition, the reporter used the device after experiencing problems with the cartridge holder. It is unclear if is the report of loose cartridge holder is relevant to the event of diabetic ketoacidosis.
 
Event Description
(b)(4). This report is associated with product compliant: (b)(4). This spontaneous case, reported a consumer who contacted the company to report an adverse event and a product complaint, with additional information provided by a second consumer, concerns a caucasian female patient born on (b)(6) 1992. The medical history of patient was not provided. It was reported that the patient had no risk factors for myocardial infarction or cardiac arrest. The concomitant medications included insulin glargine for unknown indication, and vancomycin hydrochloride, which has been used before patient experienced an infarction, for unknown indication. The patient received insulin lispro (humalog) cartridge, unknown dose, three times a day and also according to glycemia and carbohydrate counting (as reported), subcutaneously, for type i diabetes mellitus, beginning in 2001. In the beginning of treatment it was unknown how insulin lispro was delivered. On an unspecified date reported as since the patient was diagnosed with diabetes, unclear if before or after the beginning of insulin lispro therapy, the patient experienced decompensated glycemia, which was difficult to control, with hyperglycemic and hypoglycemic peaks. No information regarding corrective treatments, outcome and laboratorial examinations for decompensated glycemia was provided. In 2005, the patient started to receive insulin lispro via humapen ergo teal clear cartridge. In 2011, around 10 years after beginning insulin lispro therapy, the patient suffered a car accident, which caused a kidney injury and a femur fracture. Then, patient had to undergo an unspecified surgery, which had a complication (unspecified) and at this point a renal disorder was discovered. The car accident, traumatic kidney injury and femur fracture were considered as serious by the company due to medically significant reason. No information regarding corrective treatments and outcome for car accident, femur fracture, traumatic kidney injury, surgical complication and renal disorder was provided. On an unknown date the patient underwent peritoneal dialysis due to unknown reason and she was using vancomycin (indication not provided). On (b)(6) 2014, while patient was receiving insulin lispro via humapen ergo teal clear cartridge, the patient experienced a glycemia above 600 (unit and normal range was not provided) and was hospitalized with a ketoacidosis. At hospital she received a high replacement of physiological saline solution due to unknown reason, which caused the complete loss of kidney function (both kidneys), also described as lost de kidneys (as reported). Therefore, the patient had kidney paralysis (as reported) and she had to undergo hemodialysis every day. According to reporter the patient was placed on hemodialysis in (b)(6) 2014, during the last week of hospitalization, as a corrective treatment for renal failure. The corrective treatment for ketoacidosis was not reported. Information regarding exams and outcome for ketoacidosis and renal failure was not provided. The events of ketoacidosis and renal failure were also considered serious by the company due medically significant reasons. At the end of (b)(6) 2014, the patient was discharged from hospital. On an unspecified date, unknown time after starting insulin lispro, the patient experienced cataract and as corrective treatment she underwent an unspecified operation, laser procedure and silicone implant, however she had a retinal detachment. Cataract and retinal detachment were considered serious by the company due to medically significant reasons. Corrective treatment and outcome for retinal detachment was not provided and it was unknown if the patient recovered from cataract. On (b)(6) 2014, approximately 13 years after starting insulin lispro therapy, the patient had a myocardial infarction with the symptom of chest pain, however, the patient did not go to the hospital at the moment she experienced the infarction. It was reported that the patient went to her home and at night she underwent dialysis. At dawn the patient felt really unwell, she had a burning sensation in her stomach and chest pain. Thus, due to that, in the morning of (b)(6) 2014, the patient was hospitalized due to myocardial infarction. Because of the myocardial infarction the patient had partial heart necrosis, one coronary necrosis and another partial coronary necrosis. Still in 2014, the patient underwent a catheterization in the hospital as corrective treatment for the myocardial infarction, however, during this procedure she suffered a cardiac arrest, which was considered serious by the company due to life-threatening criteria. The patient received unspecified treatment for cardiac arrest. It was also reported that the patient underwent an angioplasty as corrective treatment for infarction, where two stents were placed. After angioplasty, the patient was taken to cti and went into a coma, which was considered as serious due to medically significant reason by the company. The patient recovered from cardiac arrest and the outcome of myocardial infarction was unknown. Then, fifteen days later, on (b)(6) 2015 while the patient was into coma, she had an ischemic stroke, which was considered serious by the company due to medically significant reason. According to reporter, the stroke affected the motor part of patient's hand, which was described as motor weakness. Also, according to reporter, the left side of patient's body became weaker after stroke she lost the strength of this side, which was reported as a sequelae of stroke. It was also stated that the ischemic stroke affected both ears on unspecified date, reported as 40 per cent hearing and 16% of understanding, no further information provided. Moreover, after stroke, the patient completely lost the sight of her left eye, which was being treated. The left eye vision loss was considered serious by the company due to disability criteria. Corrective treatment and outcome for lost the left eye vision was not provided. Information regarding corrective treatments for stroke and coma were not provided. On (b)(6) 2015, the patient awoke from the coma, therefore she recovered from it. The outcome for stroke was not provided. On an unspecified date, the patient started to receive clopidogrel (unknown manufacturer) at unknown dose, frequency, route of administration and indication for use. On (b)(6) 2015, the patient was discharged from the hospital. After that, the patient spent a weekend in home, but she was hospitalized again in (b)(6) 2015, because she experienced gastritis due to clopidogrel and was vomiting blood. No information regarding corrective treatments for gastritis and vomiting blood was provided and it was unknown if she recovered from them. The status of clopidogrel therapy was not provided. She was discharged from hospital approximately in the middle of (b)(6) 2015. On unspecified dates in 2015, the patient had more four cardiac arrests, being hospitalized several times. The cardiac arrests were considered as serious due to life-threatening criteria by the company. No further details regarding corrective treatments and start date of these cardiac arrests were provided and the patient recovered from them. On unspecified dates in 2015, the patient had several convulsive episodes and as corrective treatment she started to receive phenytoin (hidantal) unknown dose every 8 hours. Since on unspecified date and unknown time after start insulin lispro the patient underwent hemodialysis daily (except thursday and sunday) and because of that her diabetes got decompensated. She made different diets, but the glucose could not be less than 200 mg/dl (as reported). Corrective treatment was unknown and it was unknown if the patient recovered from decompensated diabetes. It was also stated that the humapen ergo teal clear cartridge holder had problems (lot number: 0404a03; product complaint number: (b)(4)) and it was unknown if its engagement tabs were broken, but it seemed to be loosen, because the cartridge holder was falling, and therefore, the reporter was afraid not to applying the right amount of insulin. Corrective treatment and outcome for the possible wrong dose administered was not provided. The patient never reused the needles and stored the pen at room temperature. Furthermore, in the beginning of (b)(6) 2016, the patient had an alteration in an unspecified liver exam, that indicated a drug-induced hepatitis caused by phenytoin, which was considered serious due to medically significant reason by the company. For this reason, phenytoin therapy was discontinued and replaced by oxcarbazepine (trileptal) unknown dose and frequency. No information regarding corrective treatments for drug-induced hepatitis was provided. It was reported that patient would undergo another liver examination to verify if drug-induced hepatitis improved or not, therefore, the outcome for this event was still unknown. As of (b)(6) 2016 the patient weighed (b)(6) but further information was not provided. Treatment with insulin lispro was ongoing. The patient and her mother operated the device and both were trained by a nurse. The patient had used this device model and the reported device since 2005 and it was unknown if it continued to be used. The device was returned on 27jun2016, and no malfunction was found. The first reporting consumer related: the renal failure to the high replacement of physiological saline solution while she was hospitalized in (b)(6) 2014; the traumatic kidney injury and femur fracture to the car accident; the gastritis to clopidogrel therapy; the convulsive episodes, left vision loss and loss of strength of left side to stroke; the drug-induced hepatitis to phenytoin therapy. The first reporting consumer did not provide an assessment of relatedness for the remaining events. The second reporting consumer did not relate the events of first cardiac arrest, myocardial infarction, patient lost left eye sight, cataract, retinal detachment, ischemic stroke, 40 per cent hearing and 16 per cent of understanding, decompensated diabetes and afraid not apply the right amount of insulin to insulin lispro therapy, but related to diabetes. The second reporting consumer did not provide an opinion of relatedness between insulin lispro and the events of diabetic ketoacidosis and renal failure and stated that renal failure was due to the high replacement of physiological saline solution. No other assessment of relatedness was provided by the second reporting consumer. Edit 17aug2016. Upon internal review, it was added another reporting consumer. Added date of birth and the patient age. Updated the event of vision loss to unilateral vision loss. Added myocardial infarction as a serious adverse event due to hospitalization. Added possible wrong dose administered as a non-serious adverse event. Removed start date for cardiac arrest. Updated the as reported for the unilateral vision loss from unilateral vision loss to patient lost left eye sight and hearing impairment as reported to 40 per cent hearing and 16% of understanding. The hospitalization box was unchecked for the cardiac arrest event. Added serious criteria of the event ischemic stroke in the narrative only. Updated relatedness opinion for both reporting consumers (changed from no to not reported). Added corrective treatment for cataract. Added product complaint number in the narrative. Fields and narrative were updated accordingly. Update 31oct2016: additional information was received from the second reporting consumer on 25oct2016. Added patient had no risk factors for myocardial infarction or cardiac arrest; updated to 2001 the start date of insulin lispro; added the serious events of diabetic ketoacidosis and renal failure; added patient received unspecified corrective treatment for cardiac arrest. Upon internal review on 31oct2016 it was corrected to no the as determined causality for the events of cataract, retinal detachment, blindness, diabetic metabolic decompensation, ischaemic stroke and cardiac arrest according to company assessment of relatedness from 03jun2016; added device subcomponent name to clear cartridge; and added no ae as degree of harm associated to event of wrong dose administered. Corresponding fields and narrative updated accordingly. Update 31oct2016: upon review, this case was opened to update the medwatch fields for regulatory reporting. The removed the device subcomponent name to clear cartridge as this was a humapen ergo teal clear cartridge holder and the subcomponent name was not needed. Update 11nov2016: additional information received on 09nov2016 from the initial reporting consumer. Added it was unknown how insulin lispro was delivered at the beginning of insulin lispro therapy; added decompensated glycemia as non-serious adverse event; added car accident, femur fracture and traumatic kidney injury as serious adverse events; added surgical complication and renal disorder as non-serious adverse event; added in third paragraph that patient started to use humapen ergo teal clear cartridge in 2005; added description regarding diabetic ketoacidosis and renal failure; added description regarding myocardial infarction and updated start date; added coma as serious adverse event; added hemiparesis as non-serious adverse event; updated narrative adding that vision loss occurred after stroke; added patient awoke from coma on (b)(6) 2015; added clopidogrel as suspected product; added gastritis and vomiting blood as serious adverse events; added new event of cardiac arrest as serious adverse event; added convulsive episodes as serious adverse events; added phenytoin as suspect product; added drug-induced (b)(6) as serious adverse event; added phenytoin was discontinued and replaced by oxcarbazepine; updated assessment of relatedness; updated narrative and corresponding fields accordingly. Upon internal review, the improper use field was updated from no to yes and device age field was updated from 2 to 11 years. Also, upon internal review, the as determined causality for the events of cataract, retinal detachment, blindness, diabetic metabolic decompensation, ischaemic stroke and first cardiac arrest was changed from no to not reported. Update 14nov2016: additional information received on 10nov2016 from the global product complaint database added the device specific safety summary, manufactured date of the device, and return date of the device; updated the malfunction field to no; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update 16nov2016. Follow up received 16nov2016 from the product complaint safety database did not contain any new information. Changed the entry date of the device specific safety summary however it did not contain any new information.
 
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Brand NameHUMAPEN ERGO, TEAL/CLEAR
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 Key6115694
MDR Text Key60434554
Report Number1819470-2016-00289
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K982842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial
Report Date 05/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS8929
Device Lot Number0404A03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2004
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: 11/19/2016 Patient Sequence Number: 1
Treatment
CLOPIDOGREL; HIDANTAL; HUMALOG; LANTUS; VANCOMICINIA
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