HUMAPEN MEMOIR

Report

Report Number: 1819470-2013-00013
Event Type: Injury
Date Received: April 16, 2013
Date of Event: July 31, 2012
Report Date: February 11, 2013
Manufacturer: ELI LILLY AND COMPANY
Product Code: NSC
PMA / PMN Number: K053563
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

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.

Additional Manufacturer Narrative · 1

IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. EVALUATION SUMMARY: A CONSUMER REPORTED THAT A FEMALE PATIENT'S HUMAPEN MEMOIR DEVICE WAS BROKEN BECAUSE THE TIME DISPLAY SOMETIMES FAILED". THE PATIENT FORGOT TO TAKE HER DOSE AND SHE WAS HOSPITALIZED FOR ABNORMAL BLOOD GLUCOSE. THE PATIENT DIED AT THE HOSPITAL DUE TO MULTIPLE MYELOMA. THE TREATING PHYSICIAN DID NOT SEE CAUSALITY BETWEEN THE DEATH OF THE PATIENT AND THE INSULIN LISPRO THERAPY NOR THE HUMAPEN MEMOIR. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. WHEN THE PEN IS POWERED ON, ALL SEGMENTS OF THE DISPLAY ARE ILLUMINATED TO CONFIRM PROPER FUNCTION. THE USER MANUAL INSTRUCTS THAT IF ANY PART OF THE PEN DISPLAY IS MISSING DO NOT USE PEN. IT FURTHER INSTRUCTS THAT IF THE DISPLAY IS NOT WORKING CORRECTLY TO CONTACT LILLY OR YOUR HEALTHCARE PROFESSIONAL. THERE IS EVIDENCE OF IMPROPER USE. THE PATIENT USED THE DEVICE WHILE THE TIME DISPLAY WAS NOT WORKING CORRECTLY.

Description of Event or Problem · 1

LILLY CASE ID: (B)(6). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY AND REPORTED AN ADVERSE EVENT, CONCERNS A FEMALE PATIENT OF UNKNOWN AGE AND ORIGIN. FURTHER INFORMATION WAS RECEIVED BY THE TREATING PHYSICIAN. NO MEDICAL HISTORY WAS REPORTED. CONCOMITANT MEDICATION INCLUDED INSULIN GLARGINE AND INSULIN HUMAN THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG CARTRIDGE) VIA A HUMAPEN MEMOIR FOR THE TREATMENT OF TYPE II DIABETES MELLITUS BEGINNING IN (B)(6) 2010 . DOSE, AND FREQUENCY WERE NOT REPORTED. IN (B)(6) 2012, GLYCOSYLATED HEMOGLOBIN WAS 6.9%. IN (B)(6) 2012, APPROXIMATELY 20 MONTHS FROM THE START OF INSULIN LISPRO, THE PATIENT FORGOT TO TAKE HER DOSE AND SHE WAS HOSPITALIZED FOR ABNORMAL BLOOD GLUCOSE (NO LAB VALUE PROVIDED). IT WAS UNCLEAR IF THE PATIENT DEVELOPED HYPOGLYCEMIA OR HYPERGLYCEMIA AND IT WAS UNKNOWN BY THE PHYSICIAN IF THE PATIENT WAS HOSPITALIZED DUE TO HYPOGLYCEMIA OR HYPERGLYCEMIA. IT WAS REPORTED THE SITUATION WAS LIFE-THREATENING AND THE PATIENT DIED AT THE HOSPITAL. THE CAUSE OF DEATH WAS REPORTED AS DUE TO MULTIPLE MYELOMA. THE PHYSICIAN DID NOT KNOW IF THE HYPOGLYCEMIA OR HYPERGLYCEMIA LED TO THE DEATH OF THE PATIENT. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE PATIENT PREVIOUSLY USED THE HUMAPEN MEMOIR DEVICE AND THE CONSUMER REPORTER BELIEVED THE PATIENT FORGOT HER DOSE BECAUSE SHE COULD NO LONGER USE THIS DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED AND NO TREATMENT WAS REPORTED. THE PATIENT WAS ON INSULIN LISPRO AT THE TIME OF DEATH. THE PATIENT OPERATED THE DEVICE AND THE TRAINING STATUS WAS NOT REPORTED. GENERAL DEVICE DURATION WAS APPROXIMATELY 20 MONTHS. SUSPECT DEVICE DURATION WAS NOT SPECIFIED. IT WAS UNKNOWN IF THE DEVICE WOULD BE RETURNED. THE TREATING PHYSICIAN DID NOT SEE A CAUSALITY BETWEEN THE DEATH OF THE PATIENT AND INSULIN LISPRO THERAPY NOR THE HUMAPEN MEMOIR. THE PHYSICIAN DID NOT KNOW IF THE ABNORMAL BLOOD GLUCOSE LED TO THE DEATH OF THE PATIENT. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF RELATEDNESS OF THE ABNORMAL BLOOD GLUCOSE, MULTIPLE MYELOMA, OR DRUG DOSE OMISSION TO INSULIN THERAPY. UPDATE: (B)(6) 2013: THIS CASE WAS MADE VALID AS THE UNKNOWN PRODUCT WAS IDENTIFIED AS INSULIN LISPRO. ADDED INSULIN LISPRO AS SUSPECT DRUG, ADDED CONCOMITANT MEDICATION, AND UPDATED NARRATIVE WITH NEW INFORMATION. UPDATE: (B)(6) 2013: ADDITIONAL INFORMATION RECEIVED (B)(6) 2013 FROM THE TREATING PHYSICIAN. ADDED HCP REPORTER AND LAB DATA. ADDED START DATE OF HUMALOG, SUSPECT HUMAPEN MEMOIR PEN, AND CONCOMITANT MEDICATION. UPDATED HUMALOG FORMULATION. ADDED MULTIPLE MYELOMA EVENT AND UPDATED CAUSALITY FOR HCP REPORTER. REMOVED DEATH CRITERIA FROM ABNORMAL BLOOD GLUCOSE EVENT AND UPDATED CAUSE OF DEATH TO MULTIPLE MYELOMA. ADDED DEVICE PARAGRAPH AND CAUSALITY STATEMENT. NARRATIVE UPDATED. ADDITIONAL CASE(S) FOR SAME PATIENT: (B)(6). UPDATE (B)(462 013: UPON REVIEW OF THIS CASE ON (B)(6) 2013, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS.

Description of Event or Problem · 1

(B)(4) THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY AND REPORTED AN ADVERSE EVENT, CONCERNS A FEMALE PATIENT OF UNKNOWN AGE AND ORIGIN. FURTHER INFORMATION WAS RECEIVED BY THE TREATING PHYSICIAN. NO MEDICAL HISTORY WAS REPORTED. CONCOMITANT MEDICATION INCLUDED INSULIN GLARGINE AND INSULIN HUMAN THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG CARTRIDGE) VIA A HUMAPEN MEMOIR FOR THE TREATMENT OF TYPE II DIABETES MELLITUS BEGINNING IN NOV-2010 . DOSE, AND FREQUENCY WERE NOT REPORTED. IN (B)(6) 2012, GLYCOSYLATED HEMOGLOBIN WAS 6.9%. IN (B)(6) 2012, APPROXIMATELY 20 MONTHS FROM THE START OF INSULIN LISPRO, THE PATIENT FORGOT TO TAKE HER DOSE AND SHE WAS HOSPITALIZED FOR ABNORMAL BLOOD GLUCOSE (NO LAB VALUE PROVIDED). IT WAS UNCLEAR IF THE PATIENT DEVELOPED HYPOGLYCEMIA OR HYPERGLYCEMIA AND IT WAS UNKNOWN BY THE PHYSICIAN IF THE PATIENT WAS HOSPITALIZED DUE TO HYPOGLYCEMIA OR HYPERGLYCEMIA. IT WAS REPORTED THE SITUATION WAS LIFE-THREATENING AND THE PATIENT DIED AT THE HOSPITAL. THE CAUSE OF DEATH WAS REPORTED AS DUE TO MULTIPLE MYELOMA. THE PHYSICIAN DID NOT KNOW IF THE HYPOGLYCEMIA OR HYPERGLYCEMIA LED TO THE DEATH OF THE PATIENT. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE PATIENT PREVIOUSLY USED THE HUMAPEN MEMOIR DEVICE AND THE CONSUMER REPORTER BELIEVED THE PATIENT FORGOT HER DOSE BECAUSE SHE COULD NO LONGER USE THIS DEVICE (PRODUCT (B)(4)/LOT UNKNOWN). NO ADDITIONAL INFORMATION WAS PROVIDED AND NO TREATMENT WAS REPORTED. THE PATIENT WAS ON INSULIN LISPRO AT THE TIME OF DEATH. THE PATIENT OPERATED THE DEVICE AND THE TRAINING STATUS WAS NOT REPORTED. GENERAL DEVICE DURATION WAS APPROXIMATELY 20 MONTHS. SUSPECT DEVICE DURATION WAS NOT SPECIFIED. THE PATIENT USED THE DEVICE WHILE THE TIME DISPLAY WAS NOT WORKING CORRECTLY (IMPROPER USE). MALFUNCTION WAS NOT KNOWN AS THE PRODUCT WAS NOT RETURNED. THE TREATING PHYSICIAN DID NOT SEE A CAUSALITY BETWEEN THE DEATH OF THE PATIENT AND INSULIN LISPRO THERAPY NOR THE HUMAPEN MEMOIR. THE PHYSICIAN DID NOT KNOW IF THE ABNORMAL BLOOD GLUCOSE LED TO THE DEATH OF THE PATIENT. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF RELATEDNESS OF THE ABNORMAL BLOOD GLUCOSE, MULTIPLE MYELOMA, OR DRUG DOSE OMISSION TO INSULIN THERAPY. UPDATE 25FEB2013: THIS CASE WAS MADE VALID AS THE UNKNOWN PRODUCT WAS IDENTIFIED AS INSULIN LISPRO. ADDED INSULIN LISPRO AS SUSPECT DRUG, ADDED CONCOMITANT MEDICATION, AND UPDATED NARRATIVE WITH NEW INFORMATION. UPDATE 26MAR2013: ADDITIONAL INFORMATION RECEIVED 25MAR2013 FROM THE TREATING PHYSICIAN. ADDED HCP REPORTER AND LAB DATA. ADDED START DATE OF INSULIN LISPRO, SUSPECT HUMAPEN MEMOIR PEN, AND CONCOMITANT MEDICATION. UPDATED HUMALOG FORMULATION. ADDED MULTIPLE MYELOMA EVENT AND UPDATED CAUSALITY FOR HCP REPORTER. REMOVED DEATH CRITERIA FROM ABNORMAL BLOOD GLUCOSE EVENT AND UPDATED CAUSE OF DEATH TO MULTIPLE MYELOMA. ADDED DEVICE PARAGRAPH AND CAUSALITY STATEMENT. NARRATIVE UPDATED. ADDITIONAL CASE FOR SAME PATIENT: (B)(4) UPDATE 12APR2013: UPON REVIEW OF THIS CASE ON 12APR2013, THE CASE WAS OPENED TO UPDATED THE MEDWATCH FIELDS. UPDATE 29AUG2013: UPON REVIEW OF THIS CASE ON 29AUG2013, THE CASE WAS OPENED TO ADD AN ACTION ITEM. UPDATE 13SEP2013: ADDITIONAL INFORMATION RECEIVED ON 13SEP2013 FROM THE AFFILIATE ADDED COMPLAINT NUMBER FOR THE MEMOIR DEVICE. UPDATE 01OCT2013. ADDITIONAL INFORMATION RECEIVED 30SEP2013 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE. TO PRODUCT PAGE ENTERED YES FOR IMPROPER USE, ADDED DEVICE SPECIFIC SAFETY SUMMARIES (DSSS), UPDATED THE EU/CA FIELDS, MEDWATCH FIELDS ACCORDINGLY, AND UPDATED THE NARRATIVE. AMENDED UPDATE STATEMENT OF 13SEP2013 TO CLARIFY COMPLAINT NUMBER WAS ADDED FOR MEMOIR DEVICE

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
162456	HUMAPEN MEMOIR	FOR TREATMENT PURPOSES	NSC	ELI LILLY AND COMPANY	MS9660

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L	LANTUS\| HUMALOG\| ACTRAPID\| INSULIN HUMAN