HUMAPEN MEMOIR

Report

Report Number: 1819470-2011-00005
Event Type: Injury
Date Received: January 7, 2011
Date of Event: December 5, 2010
Report Date: December 20, 2010
Manufacturer: ELI LILLY AND COMPANY
Product Code: NSC
PMA / PMN Number: K053563
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY THE CALLER REPORTED DASHES IN THE DISPLAY OF HER MEMOIR DEVICE, AND THE AGENT WAS ABLE TO ASSIST THE CALLER TO SUCCESSFULLY RESET THE PEN. THE CALLER ALSO STATED THAT SHE WAS NOT GETTING HER MEDICATION BECAUSE IT WAS NOT COMING OUT. NEITHER THE ACTUAL DEVICE (LOT 0811C01, MANUFACTURED NOVEMBER 2008) NOR CARTRIDGES WERE RETURNED FOR INVESTIGATION. THEREFORE, THE DEVICE COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. IMPROPER USE AND STORAGE - THERE IS EVIDENCE OF IMPROPER USE THAT MAY BE RELEVANT TO THE COMPLAINT. THE USER STATED THAT BECAUSE THERE WERE DASHES IN THE DISPLAY (I.E. THE PEN WAS IN RESET MODE), SHE HAS BEEN DOSING HER DEVICE BY COUNTING THE CLICKS, WHICH COULD RESULT IN AN INACCURATE INSULIN DOSE. THE PEN WILL GO INTO RESET MODE FOR VARIOUS REASONS, AND THERE ARE CLEAR INSTRUCTIONS IN THE USER MANUAL HOW TO RESET THE PEN.

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

(B)(4). THIS SPONTANEOUS CASE, REPORTED BY TWO CONSUMERS, WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNS A FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATION: INSULIN GLARGINE FOR AN UNSPECIFIED INDICATION. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG) VIA CARTRIDGE PER HUMAPEN MEMOIR BURGUNDY DEVICE AND INSULIN LISPRO VIA KWIKPEN AT A SET DOSE FOR THE TREATMENT OF TYPE 2 DIABETES BEGINNING RECENTLY ON AN UNSPECIFIED DATE (2010). BEGINNING ON AN UNSPECIFIED DATE, THE PATIENT HAD BEEN DOSING BY CLICKS BECAUSE THERE WERE DASHES IN THE DISPLAY OF HER HUMAPEN MEMOIR DEVICE (ASSOCIATED PRODUCT COMPLAINT (B)(4)/LOT NUMBER 0811C01 AND ASSOCIATED PRODUCT COMPLAINT (B)(4)/ LOT NUMBER UNKNOWN). SHE WAS NOT GETTING HER MEDICATION BECAUSE IT WAS NOT COMING OUT AND SHE WENT ONE DAY WITHOUT HER MEDICINE. ON (B)(6) 2010, SHE WENT TO THE EMERGENCY ROOM BECAUSE HER BLOOD SUGARS WERE TOO HIGH, SHE WAS NOT GETTING HER PROPER DOSAGE, AND OTHER UNSPECIFIED REASONS. SHE STAYED THERE FOR SEVEN HOURS BEFORE BEING RELEASED. IT WAS UNKNOWN HOW HIGH HER BLOOD SUGARS WERE. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE HER SUGARS WERE ABOUT 300 OR 400 (MG/DL). SHE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2010. REPORTEDLY, THE PATIENT DID NOT SEE WELL. TREATMENT MEASURES WERE NOT PROVIDED AND THE OUTCOME OF THE EVENTS WAS UNKNOWN. INSULIN LISPRO WAS CONTINUED. THE PATIENT OPERATED THE DEVICE AND WAS A TRAINED USER. GENERAL HUMAPEN MEMOIR DEVICE DURATION OF USE AND SUSPECT DEVICE DURATION OF USE WAS UNKNOWN. GENERAL KWIKPEN DEVICE DURATION OF USE AND SUSPECT DEVICE DURATION OF USE WAS UNKNOWN. RETURN STATUS OF PENS WAS UNKNOWN.

Description of Event or Problem · 1

(B)(4). THIS SPONTANEOUS CASE, REPORTED BY TWO CONSUMERS, WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNS A FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATION: INSULIN GLARGINE FOR AN UNSPECIFIED INDICATION. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG) VIA CARTRIDGE PER HUMAPEN MEMOIR BURGUNDY DEVICE AND INSULIN LISPRO VIA KWIKPEN AT A SET DOSE FOR THE TREATMENT OF TYPE 2 DIABETES BEGINNING RECENTLY ON AN UNSPECIFIED DATE (2010). BEGINNING ON AN UNSPECIFIED DATE, THE PATIENT HAD BEEN DOSING BY CLICKS BECAUSE THERE WERE DASHES IN THE DISPLAY OF HER HUMAPEN MEMOIR DEVICE ((B)(4)/LOT NUMBER 0811C01 AND (B)(4)/ LOT NUMBER UNKNOWN). SHE WAS NOT GETTING HER MEDICATION BECAUSE IT WAS NOT COMING OUT AND SHE WENT ONE DAY WITHOUT HER MEDICINE. ON (B)(6) 2010, SHE WENT TO THE EMERGENCY ROOM BECAUSE HER BLOOD SUGARS WERE TOO HIGH, SHE WAS NOT GETTING HER PROPER DOSAGE, AND OTHER UNSPECIFIED REASONS. SHE STAYED THERE FOR SEVEN HOURS BEFORE BEING RELEASED. IT WAS UNKNOWN HOW HIGH HER BLOOD SUGARS WERE. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE HER SUGARS WERE ABOUT 300 OR 400 (MG/DL). SHE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2010. REPORTEDLY, THE PATIENT DID NOT SEE WELL. TREATMENT MEASURES WERE NOT PROVIDED AND THE OUTCOME OF THE EVENTS WAS UNKNOWN. INSULIN LISPRO WAS CONTINUED. THE PATIENT OPERATED THE DEVICE AND WAS A TRAINED USER. GENERAL HUMAPEN MEMOIR DEVICE DURATION OF USE AND SUSPECT DEVICE DURATION OF USE WAS UNKNOWN. GENERAL KWIKPEN DEVICE DURATION OF USE AND SUSPECT DEVICE DURATION OF USE WAS UNKNOWN. THE PEN WAS NOT RETURNED. FOLLOW UP WAS ATTEMPTED AND THE REPORTER REFUSED TO PROVIDE RELEASE OF HER MEDICAL INFORMATION. SHE WAS NOT ABLE TO PROVIDE ADDITIONAL PRODUCT INFORMATION INCLUDING LOT NUMBERS AND EXPIRATION DATES AS SHE HAD PREVIOUSLY DISPOSED OF THE PRODUCT. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF A LETTER FROM THE INITIAL REPORTER ON (B)(6) -2011: THE REPORTER REFUSED TO PROVIDE ADDITIONAL INFORMATION AND REFUSED TO PROVIDE A SIGNED RELEASE OF HER MEDICAL INFORMATION. UPDATE (B)(4)-2011: ADDITIONAL INFORMATION RECEIVED (B)(4)-2011 VIA GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY AND UPDATED (B)(4) FIELDS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HUMAPEN MEMOIR	PEN INJECTOR FOR TREATMENT PURPOSES	NSC	ELI LILLY AND COMPANY	MS9660	0811C01

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization	HUMALOG\| HUMALOG