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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES

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ELI LILLY AND COMPANY HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES Back to Search Results
Model Number MS9662
Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)
Patient Problems Test Result (2695); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
No further follow up is planned. Evaluation summary: a female patient reported the injection button on her humapen luxura device "was difficult to push down, without making clicking sounds. " she experienced abnormal blood glucose levels. The device was not returned for investigation (batch number unknown). Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction. Malfunction unknown. 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
(b)(4). This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) asian female patient. Medical history included allergy to penicillin and streptomycin. Concomitant medication included metformin hydrochloride for an unspecified indication. The patient received insulin lispro protamine suspension 50% insulin lispro 50% (rdna origin (humalog mix50) via a reusable pen (humapen luxura), 20 iu in the morning, 7 iu in the noon and 8 iu in the evening, subcutaneously for the treatment of diabetes and beginning around 2012. Reportedly, the injection button of the humapen luxura was difficult to push down and did not make clicking sounds (product complaint (b)(4), batch unknown). Sometime, she experienced unstable blood sugars and cerebrovascular jam. Due to these events, she was hospitalized for ten days. Laboratory findings and hospitalization dates were not provided as well as corrective treatments and the outcome of the events. Insulin lispro protamine suspension therapy was ongoing. The user of the humapen luxura and his/her training status were not provided. She had used this type of device since 2012 (conflicting information of 2009). The humapen luxura was not returned to the manufacturer. The reporting consumer did not know if the events were related to insulin lispro protamine suspension therapy and did not provide any assessment for the humapen luxura. Edit 28mar2017. Case was opened to enter medwatch device fields and european/canadian device fields for device mailing. No new information. Update 30-mar-2017: additional information received from local affiliate on 28-mar-2017, without information from reporter because after several calls the reporter refused to pick up the phone. No additional changes were made to the case. Update 05-apr-2017: additional information received from local affiliate on 01-apr-2017 stated that the consumer was busy and could not receive follow up. No other changes were made to the case. Update 11-apr-2017: pc (b)(4) was received on 11-apr-2017. Processed pc accordingly and added to narrative. Updated device type from humapen unknown type to humapen luxura burgundy. No further changes were performed to the case. Update 14apr2017: additional information received on 14apr2017 from the global product complaint database. Entered device specific safety summary (dsss). Updated the medwatch fields with device information and the european and canadian (eu/ca) device information. Corresponding fields and narrative updated accordingly.
 
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Brand NameHUMAPEN LUXURA BURGUNDY
Type of DeviceFOR TREATMENT PURPOSES
Manufacturer (Section D)
ELI LILLY AND COMPANY
lilly corporate center
indianapolis IN 46285
Manufacturer (Section G)
PHILLIPS-MEDISIZE CORPORATION
medical device manufacturing
415 red cedar street
menomonie WI 54751
Manufacturer Contact
caroline rosewell
lilly corporate center
indianapolis, IN 46285
3172764376
MDR Report Key6499781
MDR Text Key73022521
Report Number1819470-2017-00064
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K142518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 04/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMS9662
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2017
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: 04/18/2017 Patient Sequence Number: 1
Treatment
INSULIN LISPRO; MELBIN
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