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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN ERGO II FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9557
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hearing Loss (1882); High Blood Pressure/ Hypertension (1908); Hypoglycemia (1912); Numbness (2415); Diaphoresis (2452)
Event Date 10/10/2016
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 report will be submitted when the final evaluation has been completed.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via a psp, concerned an (b)(6) female patient. Medical history included cataract, hypertension, coronary heart disease, osteoproliferation, her ears and heart were not good, a myocardial and a cerebral infarction, bony spur, melancholia and she previously used human insulin 30/70 through a vial. Concomitant medications included acarbose for unknown indication. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin mix 70/30) from a cartridge via reusable pen (humapen ergo ii), subcutaneously, 22 in the morning and 10 in the evening (no units provided) for the treatment of diabetes mellitus, beginning on (b)(6) 2016. On an unspecified date her dosage regimen was changed to 18 at morning and 4 at night (no units provided) for an unknown reason. While on human insulin 30/70 treatment, she could not hear clearly. On (b)(6) 2016 (conflictive information), she could not rise up at 16:00hr. Reportedly, because she injected without mixing the cartridge it could have caused that her hands were numb, had sweating and she might be on hypoglycemia; her fasting blood glucose was 3. 6 (no reference ranges) and her postprandial blood glucose was 11 (no reference ranges). No more details provided. By (b)(6) 2016, she was recovering from the symptoms after eating some chocolate and it was unknown if she was recovered from the event of hearing impaired. On (b)(6) 2016 she had hypoglycemia and high blood pressure; her blood glucose measured value was 2-3 (no units or reference values provided). It was reported that she would go to the hospital as outpatient for treatment. The event of hypoglycemia occurred on (b)(6) 2016 was considered serious for medical significance. Because the injection pen appeared breakdown, she used disposable syringes to extract and inject the insulin from cartridge. Information regarding corrective treatments and the outcome of the events of hypoglycemia and high blood pressure was not provided. Human insulin 30/70 treatment was ongoing. The operator of the humapen ergo ii was the patient and her training status was not reported. The general humapen ergo ii duration of use was not provided, but started in (b)(6) 2016 and the suspect humapen ergo ii duration of use was not reported. The action taken and the return status of the suspect device were unknown. The reporting consumer did not know if the events were related to human insulin 30/70 treatment. Update 13-oct-2016: additional information received from the initial reporter via a psp on 10-oct-2016 and on 11-oct-2016 were processed at the same time. This case was upgraded due to the serious event of hypoglycemia. Added medical history, relevant lab data, a new dosage regimen, a suspect device, the non-serious event of high blood pressure and the serious event of hypoglycemia. Upon internal review it was added the event of wrong injection technique. Narrative was updated with new information. Edit 14oct2016. Case was opened to enter medwatch device fields and the to update the european/canadian device fields for device mailing. No new information.
 
Manufacturer Narrative
Narrative - new, updated and corrected information is referenced within the update statements in describe event or problem. Please refer to update statement dated 10nov2016 in the describe event or problem. No further follow up is planned.
 
Event Description
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), with additional information from the initial reporter via a psp, concerned an (b)(6) female patient. Medical history included cataract, hypertension, coronary heart disease, osteoproliferation, her ears and heart were not good, a myocardial and a cerebral infarction, bony spur, melancholia and she previously used human insulin 30/70 through a vial. Concomitant medications included acarbose for unknown indication. The patient received human insulin isophane suspension 70%/human insulin 30% (rdna origin) injections (humulin mix 70/30) from a cartridge via reusable pen (humapen ergo ii), subcutaneously, 22 in the morning and 10 in the evening (no units provided) for the treatment of diabetes mellitus, beginning on (b)(6) 2016. On an unspecified date her dosage regimen was changed to 18 at morning and 4 at night (no units provided) for an unknown reason. While on human insulin 30/70 treatment, she could not hear clearly. On (b)(6) 2016 (conflictive information), she could not rise up at 16:00hr. Reportedly, because she injected without mixing the cartridge it could have caused that her hands were numb, had sweating and she might be on hypoglycemia; her fasting blood glucose was 3. 6 (no reference ranges) and her postprandial blood glucose was 11 (no reference ranges). No more details provided. By (b)(6) 2016, she was recovering from the symptoms after eating some chocolate and it was unknown if she was recovered from the event of hearing impaired. On (b)(6) 2016 she had hypoglycemia and high blood pressure; her blood glucose measured value was 2-3 (no units or reference values provided). It was reported that she would go to the hospital as outpatient for treatment. The event of hypoglycemia occurred on (b)(6) 2016 was considered serious for medical significance. Because the injection pen appeared breakdown, she used disposable syringes to extract and inject the insulin from cartridge. Information regarding corrective treatments and the outcome of the events of hypoglycemia and high blood pressure was not provided. Human insulin 30/70 treatment was ongoing. The operator of the humapen ergo ii was the patient and her training status was not reported. The general humapen ergo ii duration of use was not provided, but started in (b)(6) 2016 and the suspect humapen ergo ii duration of use was not reported. The device was not returned. The reporting consumer did not know if the events were related to human insulin 30/70 treatment. Update 13-oct-2016: additional information received from the initial reporter via a psp on 10-oct-2016 and on 11-oct-2016 were processed at the same time. This case was upgraded due to the serious event of hypoglycemia. Added medical history, relevant lab data, a new dosage regimen, a suspect device, the non-serious event of high blood pressure and the serious event of hypoglycemia. Upon internal review it was added the event of wrong injection technique. Narrative was updated with new information. Edit 14oct2016. Case was opened to enter medwatch device fields and to update the european/canadian device fields for device mailing. No new information. Update 10-nov-2016: additional information received on 09-nov-2016 from the global product complaint database added the device specific safety summary; added the device was not returned; updated the medwatch and european and canadian required device reporting elements; and updated the narrative. Update 22-nov-2016: information received from the rcp on 11-oct-2016. Product complaint reference number was received. No adverse event information was received.
 
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Brand NameHUMAPEN ERGO II
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 Key6067716
MDR Text Key58795522
Report Number1819470-2016-00272
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMS9557
Device Lot Number1501001
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
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: 10/31/2016 Patient Sequence Number: 1
Treatment
GLUCOBAY; INSULIN HUMAN
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