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Model Number UNKNOWN
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Asthma (1726); Fatigue (1849); Fever (1858); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912); Pain (1994); Respiratory Distress (2045); Thrombosis (2100); Thyroid Problems (2102); Visual Disturbances (2140); Cramp(s) (2193); Dizziness (2194); Myalgia (2238); Diabetic Ketoacidosis (2364); Sweating (2444); Shaking/Tremors (2515); Weight Changes (2607)
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
(b)(4). This solicited case reported by a consumer via a patient support program (psp), with additional information from initial consumer reporter via psp, concerned a (b)(6) female patient. Medical history included being diagnosed with diabetes in 1993, pancreatitis, bilateral cerebral thrombosis, renal function is not good, high blood pressure, asthma, lumbar and vertebrae had problems, she was allergic to insects, and that her mother, grandmother, aunt and brother had diabetes. Historical insulin human injection, isophane for unknown indication. Be allergic to metformin hydrochloride, benzylpenicillin, sulfonamides and bupleurum falcatum injection. She felt uncomfortable after using gliguidone. Concomitant medications included insulin glargine, acarbose, pioglitazone hydrochloride, all for type 2 diabetes mellitus; and fluticasone propionate/salmeterol xinafoate, bunaide (as reported), and dubao(turbuhaler) (as reported) for the treatment of asthma. The patient received human insulin (rdna origin) injection (humulin r) and human insulin isophane suspension (rdna origin) injection (humulin n) bothl via cartridge all through reusable pen (humapen), subcutaneously for the treatment of type 2 diabetes mellitus beginning in 1998. She received insulin lispro protamine suspension 50%/ insulin lispro 50% (rdna origin) injections (humalog mix50); dosage regimen and start date were not reported. Also she received pioglitazone hydrochloride unknown formulation, for type 2 diabetes mellitus. Dosage regimen and start date of treatment were not reported. On unknown date, while on human insulin and human insulin isophane suspension, she experienced hypothyroidism, asthma attack, and hypoglycemia; so, in 2004, she discontinued human insulin and human insulin isophane suspension and started receiving insulin lispro (rdna origin) injection (humalog) via cartridge 20 (units not reported) three times daily subcutaneously, for the treatment of type 2 diabetes. On unknown date while on insulin lispro, she had coronary artery disease and her eyes were not ok. Sometime after using insulin, eyesight was not good. On (b)(6) 2017, while on therapy, her blood glucose (bg) was a little high (no units and values were given), it related to the diet. Sometime during human insulin and human insulin isophane suspension, when her blood glucose was a little more than six (no units were given), she had ketosis, as per physician it was starvation ketoacidosis. Her ketonuria had one to four plus (no units were given). She had aching pain, and cramp after high fever. On unspecified date, she had hypoglycemia, a large amount of sweating and trembles. Her bg was a little more than two or a little more than three (no units and reference values were given). When she experienced hypoglycemia, she drank 500 ml beverage, then the blood glucose increased. On (b)(6) 2017, during the labor holiday of, she ate more fat. After (b)(6) 2017, her bg had a large fluctuation and was high (no values provided). Her bg was a little more than 17 in one day (units were not reported). The doctor believed that maybe it was insulin resistance and advised her to add four units but she added six units by herself. Her blood glucose decreased 2 mmol/l; she felt, the reason was that she ate two sugarless gums. On (b)(6) 2017, she was allergic to acarbose and was hospitalized. As of (b)(6) 2017, she was still hospitalized. On an unspecified date, she was in hospital (unspecified reason) and used human insulin treatment. On an unspecified date, while in human insulin treatment, she experienced asthma due to treatment was changed to insulin lispro treatment. When her bg was stable (values or units not reported), she administered human insulin, human insulin isophane suspension and insulin lispro treatment. On an unspecified date, she administered insulin lispro protamine suspension 50%/ insulin lispro 50% treatment, her bg was very high (values or units not reported). She had asthma, urine amylase and urine protein test (values or units not reported). She used an unspecified hormone for 7 days and the asthma was controlled, but her bg increased 2 to 3 (units not reported). She experienced sweating and shock. On an unspecified date, while on insulin lispro treatment, she experienced asthma and could not eat meal, so she had to stop administrating insulin lispro and acarbose at that meal according to physician's advice. On an unspecified date, after administrating pioglitazone hydrochloride, she experienced muscle pain, body fester, transaminase increasing and weight increasing seriously; she did not use it sometimes. On an unknown date, when the blood glucose had larger fluctuation, the pioglitazone hydrochloride would be added to 45 mg. When she took 45 mg, she experienced muscle pain. On an unspecified date, her blood pressure was unstable (values or units not reported), she received nifedipine and fosinopril sodium as corrective treatment and blood pressure was controlled stable. It was unknown if hypertension appeared before or after using insulins. On an unspecified date, her kidney was not good, it was unknown when did nephropathy started. She received a traditional chinese medicine bailing and kaitong (as reported) as corrective treatment. In (b)(6) 2015, while on insulin lispro treatment, she experienced a cerebral thrombosis, now the cerebral thrombosis was controlled well (conflicting information, also reported as medical history). This event was considered serious due to medical significance. In (b)(6) 2017, at midnight, she had hypoglycemia, so she drank a yoghurt and sugar free flower cake. On (b)(6) 2017, she got cold with cough and bronchial asthma attacked; she thought it was due to the season. She started receiving unspecified hormone for asthma, but she started gaining weight. As of (b)(6) 2017, she weighed more than 80 kg. On an unknown date, the blood glucose was bit more than 13, the highest was 19. According to the condition of blood glucose, she increased 3-4 units of insulin by herself. On (b)(6) 2017, she had waist pain. As of (b)(6) 2018, she was hospitalized for the treatment on (b)(6) 2018 due to blood glucose unstable and dizziness. She had an intravenous drip for the treatment and outcome was not provided. She was recovering from asthma. Information regarding outcome of the remaining events, corrective treatment of the remaining invents and insulin lispro protamine suspension 50%/ insulin lispro 50% was not reported. Human insulin and human insulin isophane suspension treatment was discontinued and their status after discontinuation was unknown. Insulin lispro treatment was continued. The operator of the device and his/her training status was not provided. The humapen duration was not provided. The reported humapen duration of use was not reported (product complaint (pc): (b)(4) / lot: unknown). The action taken with the humapen was not provided and its return was not expected. The reporting consumer did not provide an assessment of relatedness between the events and insulin lispro, insulin lispro protamine suspension 50%/ insulin lispro 50% human insulin and human insulin isophane suspension treatment; thought cerebral thrombosis, asthma, not good kidney function, hypertension were related with too old, immune and stress; and assessed weight increased was related to unspecified hormone. Her treating physician assessed muscle pain, body fester, transaminase increasing, weight increasing seriously were related with pioglitazone hydrochloride treatment. This case was crossed referenced with (b)(4) with the same reporter. Update 10-may-2017: information received via a psp on 02-may-2017. (b)(4) were received but not available. No changes were performed to the case. Edit 18-may-2017: upon internal review of information received on 27-apr-2017, it was added suspect humapen to process pc 3977830. Updated narrative with product complaint information. Update 22-jun-2017: information received on 19-jun-2017 by local affiliate. No follow up would be attempted because the hcp contact details were not provided. No changes were made to the case. Update 27-oct-2017: it was determined on 23-oct-2017 (b)(4) was a follow up of this (b)(4); therefore, (b)(4) was deleted, and information contained in (b)(4) was captured in this (b)(4). Additional information received on 18-oct-2017 from initial reporter via psp. Added medical history of spinal disorder; weight lab data; concomitant medications of fluticasone propionate salmeterol xinafoate, bunaide and dubao; insulin lispro start date; human insulin and human insulin isophane suspension start and discontinuation date; the non-serious event of hypothyroidism, second and third hypoglycemia, coronary artery disease, eye disorder, viral upper respiratory tract infection; corrective treatment information for asthma; and same reporter linked case. Updated family history of diabetes, medical history of cerebral thrombosis to bilateral medical history; action taken with human insulin and human insulin isophane suspension to drug discontinued; the non-serious events of weight increased, asthma and outcome of asthma to recovering. Updated narrative accordingly. Update 07-nov-2017: information received on 31-oct-2017 from initial reporter. Updated hcp contact details. No changes were made to the case. Update 14-nov-2017: additional information from the initial reporter was received on 09-nov-2017. Added non-serious events of hyperglycaemia, visual impairment and waist pain. Added lab data of blood glucose. Updated narrative with new information. Update 03-jul-2018: information received on 27-jun-2018, added the serious event of dizziness and upgraded the non-serious event of blood glucose unstable to serious due to hospitalization. No other changes were made to the case. Edit 07-sep-2018: upon review of the information received on 27-jun-2018, device was marked as significant, accordingly eu/ca were updated. No other changes were made to the case. Edit 07sep2018: updated medwatch and european and canadian (eu/ca) fields for expedited device reporting. No new information added.
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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 Key7861475
MDR Text Key119735790
Report Number1819470-2018-00169
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
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 Received09/13/2018
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: 09/10/2018 Patient Sequence Number: 1