FREESTYLE LIBRE 14 DAY
Report
- Report Number
- 2954323-2023-38965
- Event Type
- Injury
- Date Received
- September 5, 2023
- Date of Event
- August 28, 2023
- Report Date
- August 7, 2024
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- PZE
- PMA / PMN Number
- P160030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
THIS SERVES AS A CORRECTION REPORT. SECTION(S) UPDATED AS FOLLOWS: D1 - BRAND NAME TO FREESTYLE LIBRE 14 DAY FROM FREESTYLE LIBRE 2. D2B - PROCODE TO PZE FROM QLG. D4 - MODEL # TO 71938-01 FROM 71953-01. G4 - PMA/510(K) # TO P160030 FROM K193371.
THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN 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 DHRS (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE READER WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THIS SERVES AS A CORRECTION REPORT. SECTION(S) UPDATED AS FOLLOWS: H2: UPDATED TO DEVICE EVALUATION FROM NONE. H3: UPDATED TO YES FROM NO. H4: DEVICE MFG DATE. H6: UPDATED ON TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND CONCLUSIONS.
THE RETURNED READER (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED ON THE USB/CHARGING CABLE AND NO ISSUES WERE OBSERVED. THE USB/CHARGING CABLE HAS PASSED TESTING. THE READER WAS VISUALLY INSPECTED AND DAMAGED USB PORT AND LIQUID CONTAMINATION WAS OBSERVED. THE DAMAGED USB PORT WOULD PREVENT THE CUSTOMER FROM CHARGING THE READER WHICH WOULD LEAD TO THE READER NOT TURNING ON. THE RETURNED READER WAS DE-CASED AND ATTEMPTED TO DOWNLOAD READER DATA WHILE IN THE TEST FIXTURE. UNABLE TO DOWNLOAD READER DATA DUE TO DAMAGE AND LIQUID CONTAMINATION IN USB. AN EXTENDED VISUAL INSPECTION HAS BEEN PERFORMED ON THE RETURNED DE-CASED READER, OBSERVED DAMAGE AND LIQUID INGRESS TO USB CHARGING PORT. THE RETURNED CHARGING CABLE WAS TESTED USING CABLE TESTER, NO SHORTS OR OPEN CIRCUITS OBSERVED. RETURNED READER DOES NOT TURN ON WITH BUTTON PRESS, STRIP OR CABLE INSERTION. RETURNED READER WAS DE-CASED. THE RETURNED BATTERY WAS MEASURED AND RESULTS WERE NOT WITHIN SPECIFICATION. RETURNED BATTERY WAS REPLACED WITH A KNOWN GOOD BATTERY AND OBSERVED RETURNED READER TO TURN ON WITH BUTTON PRESS. DATA WAS UNABLE TO EXTRACTED DIRECTLY FROM THE READER DUE TO THE DAMAGE AND LIQUID INGRESS OBSERVED TO THE CHARGING/DATA PORT. RETURNED READER WAS PLACED INTO THE READER FIXTURE AND WAS ABLE TO EXTRACT DATA. NO CONNECTED TO PC MESSAGE WAS DISPLAYED WHEN RETURNED READER TURNED ON AND WHEN PLACED INTO THE FIXTURE PC MESSAGE OBSERVED AND WHEN REMOVED FROM FIXTURE MESSAGE DISAPPEARS. ISSUE IS NOT CONFIRMED TO USE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE READER (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED ON THE USB/CHARGING CABLE AND NO ISSUES WERE OBSERVED. THE USB/CHARGING CABLE HAS PASSED TESTING. THE READER WAS VISUALLY INSPECTED AND DAMAGED USB PORT AND LIQUID CONTAMINATION WAS OBSERVED. THE DAMAGED USB PORT WOULD PREVENT THE CUSTOMER FROM CHARGING THE READER WHICH WOULD LEAD TO THE READER NOT TURNING ON. THE RETURNED READER WAS DE-CASED AND ATTEMPTED TO DOWNLOAD READER DATA WHILE IN THE TEST FIXTURE. UNABLE TO DOWNLOAD READER DATA DUE TO DAMAGE AND LIQUID CONTAMINATION IN USB. AN EXTENDED VISUAL INSPECTION HAS BEEN PERFORMED ON THE RETURNED DE-CASED READER, OBSERVED DAMAGE AND LIQUID INGRESS TO USB CHARGING PORT. THE RETURNED CHARGING CABLE WAS TESTED USING CABLE TESTER, NO SHORTS OR OPEN CIRCUITS WERE OBSERVED. RETURNED READER DOES NOT TURN ON WITH BUTTON PRESS, STRIP OR CABLE INSERTION. RETURNED READER WAS DE-CASED. THE RETURNED BATTERY WAS MEASURED AND RESULTS WERE NOT WITHIN SPECIFICATION. RETURNED BATTERY WAS REPLACED WITH A KNOWN GOOD BATTERY AND OBSERVED RETURNED READER TO TURN ON WITH BUTTON DEPRESSION. DATA WAS UNABLE TO EXTRACTED DIRECTLY FROM THE READER DUE TO THE DAMAGE AND LIQUID INGRESS OBSERVED TO THE CHARGING/DATA PORT. RETURNED READER WAS PLACED INTO THE READER FIXTURE AND WAS ABLE TO EXTRACT DATA. NO CONNECTED TO PC MESSAGE WAS DISPLAYED WHEN RETURNED READER TURNED ON AND WHEN PLACED INTO THE FIXTURE PC MESSAGE OBSERVED AND WHEN REMOVED FROM FIXTURE MESSAGE DISAPPEARS. THEREFORE, ISSUE IS NOT CONFIRMED TO USE. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT. THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE READER WAS REVIEWED AND THE DHRS SHOWED THE LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. IN ADDITION, THE REVIEW DETERMINED THAT THE CORRECT CABLE WAS PART OF THE READER KIT PACK AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATIONS. THIS SERVES AS A CORRECTION REPORT. SECTION H11 (ADDITIONAL MFG NARRATIVE) WAS INCORRECTLY UPDATED IN THE PREVIOUS REPORT. CORRECTION HAS BEEN MADE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MANUFACTURING DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A DISPLAY MESSAGE WAS REPORTED WITH THE ADC DEVICE. A "CONNECTED TO PC" MESSAGE DISPLAYED WHEN THE DEVICE WAS NOT CONNECTED TO A COMPUTER, AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER FELT AN UNSPECIFIED HYPOGLYCEMIA SYMPTOMS AND WAS TREATED "WITH FOOD THAT CONTAINS GLUCOSE" BY A NON-HEALTH PROFESSIONAL . THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
A DISPLAY MESSAGE WAS REPORTED WITH THE ADC DEVICE. A "CONNECTED TO PC" MESSAGE DISPLAYED WHEN THE DEVICE WAS NOT CONNECTED TO A COMPUTER, AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER FELT AN UNSPECIFIED HYPOGLYCEMIA SYMPTOMS AND WAS TREATED "WITH FOOD THAT CONTAINS GLUCOSE" BY A NON-HEALTH PROFESSIONAL . THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
A DISPLAY MESSAGE WAS REPORTED WITH THE ADC DEVICE. A "CONNECTED TO PC" MESSAGE DISPLAYED WHEN THE DEVICE WAS NOT CONNECTED TO A COMPUTER, AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER FELT AN UNSPECIFIED HYPOGLYCEMIA SYMPTOMS AND WAS TREATED "WITH FOOD THAT CONTAINS GLUCOSE" BY A NON-HEALTH PROFESSIONAL . THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
A DISPLAY MESSAGE WAS REPORTED WITH THE ADC DEVICE. A "CONNECTED TO PC" MESSAGE DISPLAYED WHEN THE DEVICE WAS NOT CONNECTED TO A COMPUTER, AND CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER FELT AN UNSPECIFIED HYPOGLYCEMIA SYMPTOMS AND WAS TREATED "WITH FOOD THAT CONTAINS GLUCOSE" BY A NON-HEALTH PROFESSIONAL . THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2224552 | FREESTYLE LIBRE 14 DAY | FLASH GLUCOSE MONITORING SYSTEM | PZE | ABBOTT DIABETES CARE INC | 71938-01 | ||
| 76930 | FREESTYLE LIBRE 14 DAY | FLASH GLUCOSE MONITORING SYSTEM | PZE | ABBOTT DIABETES CARE INC | 71938-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |