FREESTYLE LIBRE

Report

Report Number: 2954323-2017-09127
Event Type: Injury
Date Received: December 27, 2017
Date of Event: November 23, 2017
Report Date: November 20, 2018
Manufacturer: ABBOTT DIABETES CARE INC.
Product Code: PZE
PMA / PMN Number: P160030
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SE
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE REPORTED COMPLAINT DOES NOT PERTAIN TO THE FREESTYLE LIBRE READER. THEREFORE NO FURTHER INVESTIGATION INTO THE READER WILL BE REQUIRED. A DHR (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE SENSORS AND FREESTYLE LIBRE SENSOR KITS WERE REVIEWED AND THE DHR SHOWED THE LIBRE SENSORS AND SENSORS KIT PASSED ALL TESTS PRIOR TO RELEASE. ALL REVIEW ACTIVITIES CONDUCTED ABOVE, INCLUDING BUT NOT LIMITED TO THE FINAL RELEASE TESTING SPECIFICALLY ASSOCIATED WITH THE MANUFACTURE OF THIS PRODUCT, ARE SUFFICIENT INFORMATION IN ORDER TO SHOW IF THE PRODUCT HAS MET SPECIFICATIONS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.

Additional Manufacturer Narrative · 1

THIS SERVES AS A CORRECTION REPORT. (DATE OF EVENT) AND (SUSPECT MEDICAL DEVICE) WERE INCORRECTLY DOCUMENTED IN THE INITIAL MDR 30 DAY REPORT.

Additional Manufacturer Narrative · 1

THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF MFG IS UNKNOWN. THE DATE REPORTED, IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

Description of Event or Problem · 1

A NURSE REPORTED THE CUSTOMER'S ADC FREESTYLE LIBRE SENSOR PRODUCE A LOWER RESULT THAN A LABORATORY TEST RESULT. IT WAS REPORTED THAT ON (B)(6) THE CUSTOMER, WHO IS ON DIALYSIS, BEGAN TO "FEEL SICK" AND EXPERIENCED VOMITING. ON (B)(6) AT 17:00, THE CUSTOMER EXPERIENCED "SHAKING, COLD SWEATS, VOMITING, FELT SICK, HARD TO FOCUS WHEN TALKING" AND WAS TAKEN TO A HOSPITAL. AT THE HOSPITAL A LABORATORY RESULT OF 60 MMOL/L (1080 MG/DL) WAS OBTAINED AND COMPARED TO A SENSOR SCAN RESULT OF 10 MMOL/L (180 MG/DL) OBTAINED WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 'OUT OF RANGE' SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. CUSTOMER WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU) AT 17:22, DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND HYPONATREMIA, AND TREATED WITH INSULIN VIA INTRAVENOUS INFUSION. CUSTOMER WAS TRANSFERRED TO THE "MEDICAL DEPARTMENT" AT 24:00. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

Description of Event or Problem · 1

A NURSE REPORTED THE CUSTOMER'S ADC FREESTYLE LIBRE SENSOR PRODUCE A LOWER RESULT THAN A LABORATORY TEST RESULT. IT WAS REPORTED THAT ON (B)(6) THE CUSTOMER, WHO IS ON DIALYSIS, BEGAN TO "FEEL SICK" AND EXPERIENCED VOMITING. ON (B)(6) AT 17:00, THE CUSTOMER EXPERIENCED "SHAKING, COLD SWEATS, VOMITING, FELT SICK, HARD TO FOCUS WHEN TALKING" AND WAS TAKEN TO A HOSPITAL. AT THE HOSPITAL A LABORATORY RESULT OF 60 MMOL/L (1080 MG/DL) WAS OBTAINED AND COMPARED TO A SENSOR SCAN RESULT OF 10 MMOL/L (180 MG/DL) OBTAINED WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 'OUT OF RANGE' SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. CUSTOMER WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU) AT 17:22, DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND HYPONATREMIA, AND TREATED WITH INSULIN VIA INTRAVENOUS INFUSION. CUSTOMER WAS TRANSFERRED TO THE "MEDICAL DEPARTMENT" AT 24:00. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

Description of Event or Problem · 1

A NURSE REPORTED THE CUSTOMER'S ADC FREESTYLE LIBRE SENSOR PRODUCE A LOWER RESULT THAN A LABORATORY TEST RESULT. IT WAS REPORTED THAT ON (B)(6) THE CUSTOMER, WHO IS ON DIALYSIS, BEGAN TO "FEEL SICK" AND EXPERIENCED VOMITING. ON (B)(6) AT 17:00, THE CUSTOMER EXPERIENCED "SHAKING, COLD SWEATS, VOMITING, FELT SICK, HARD TO FOCUS WHEN TALKING" AND WAS TAKEN TO A HOSPITAL. AT THE HOSPITAL A LABORATORY RESULT OF 60 MMOL/L (1080 MG/DL) WAS OBTAINED AND COMPARED TO A SENSOR SCAN RESULT OF 10 MMOL/L (180 MG/DL) OBTAINED WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL 'OUT OF RANGE' SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. CUSTOMER WAS ADMITTED INTO THE INTENSIVE CARE UNIT (ICU) AT 17:22, DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND HYPONATREMIA, AND TREATED WITH INSULIN VIA INTRAVENOUS INFUSION. CUSTOMER WAS TRANSFERRED TO THE "MEDICAL DEPARTMENT" AT 24:00. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
928646	FREESTYLE LIBRE	FLASH GLUCOSE MONITORING SYSTEM	PZE	ABBOTT DIABETES CARE INC.	71702-01

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention