LIBRE BLOOD SUGAR MONITOR
Report
- Report Number
- MW5158244
- Event Type
- Malfunction
- Date Received
- August 7, 2024
- Date of Event
- July 24, 2024
- Report Date
- August 4, 2024
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- QLG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MT, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
INCORRECT READING OF SENSOR. THE READER SHOWED MY BLOOD SUGAR LEVELS ABOVE 300 PLUS. ALARMS ON MY READER KEPT GOING OFF. MADE ME BELIEVE MY LEVELS WERE GOING UP AND UP. CAUSE PANIC ATTACKS, THOUGHT I NEEDED TO BOOST MY INSULIN INJECTIONS. AFTER 2 DAYS OF THIS, SLOWLY INCREASING MY INSULIN TO A LOT MORE THAN USUAL WITH NO DECLINE IN SUGAR LEVELS. ON THE 3RD DAY I TOOK HALF USED SENSOR AND REPLACE WITH A NEW ONE. EVERYTHING WENT TO NORMAL. THIS WAS SCARY BECAUSE I COULD HAVE OVERDOSED ON INSULIN. I TOSSED THE OLD SENSOR NOT THINKING I SHOULD HAVE KEPT IT TO SEND BACK. I DON'T HAVE THE SERIAL, OR THE UNIT. I TOSSED IT NOT THINKING I WOULD NEED IT AGAIN.
ADDITIONAL INFORMATION RECEIVED ON 8/14/2024 FOR REPORT MW5158244. INCORRECT READING OF SENSOR. THE READER SHOWED MY BLOOD SUGAR LEVELS ABOVE 300 PLUS. ALARMS ON MY READER KEPT GOING OF. MADE ME BELIEVED MY LEVELS WERE GOING UP AND UP. CAUSE PANIC ATTACKS, THOUGHT I NEEDED TO BOOST MY INSULIN INJECTIONS. AFTER 2 DAYS OF THIS, SLOWLY INCREASING MY INSULIN TO A LOT MORE THAN USUAL WITH NO DECLINE IN SUGAR LEVELS. ON THE 3RD DAY I TOOK HALF USED SENSOR AND REPLACE WITH A NEW ONE. EVERYTHING WENT TO NORMAL. THIS WAS SCARY BECAUSE I COULD HAVE OVERDOSED ON INSULIN. I TOSSED THE OLD SENSOR NOT THINKING I SHOULD HAVE KEPT IT TO SEND BACK. PROCODE: QLG.
INCORRECT READING OF SENSOR. THE READER SHOWED MY BLOOD SUGAR LEVELS ABOVE 300 PLUS. ALARMS ON MY READER KEPT GOING OFF. MADE ME BELIEVE MY LEVELS WERE GOING UP AND UP. CAUSE PANIC ATTACKS, THOUGHT I NEEDED TO BOOST MY INSULIN INJECTIONS. AFTER 2 DAYS OF THIS, SLOWLY INCREASING MY INSULIN TO A LOT MORE THAN USUAL WITH NO DECLINE IN SUGAR LEVELS. ON THE 3RD DAY I TOOK HALF USED SENSOR AND REPLACE WITH A NEW ONE. EVERYTHING WENT TO NORMAL. THIS WAS SCARY BECAUSE I COULD HAVE OVERDOSED ON INSULIN. I TOSSED THE OLD SENSOR NOT THINKING I SHOULD HAVE KEPT IT TO SEND BACK. I DON'T HAVE THE SERIAL, OR THE UNIT. I TOSSED IT NOT THINKING I WOULD NEED IT AGAIN.
ADDITIONAL INFORMATION RECEIVED ON 8/14/2024 FOR REPORT MW5158244. INCORRECT READING OF SENSOR. THE READER SHOWED MY BLOOD SUGAR LEVELS ABOVE 300 PLUS. ALARMS ON MY READER KEPT GOING OF. MADE ME BELIEVED MY LEVELS WERE GOING UP AND UP. CAUSE PANIC ATTACKS, THOUGHT I NEEDED TO BOOST MY INSULIN INJECTIONS. AFTER 2 DAYS OF THIS, SLOWLY INCREASING MY INSULIN TO A LOT MORE THAN USUAL WITH NO DECLINE IN SUGAR LEVELS. ON THE 3RD DAY I TOOK HALF USED SENSOR AND REPLACE WITH A NEW ONE. EVERYTHING WENT TO NORMAL. THIS WAS SCARY BECAUSE I COULD HAVE OVERDOSED ON INSULIN. I TOSSED THE OLD SENSOR NOT THINKING I SHOULD HAVE KEPT IT TO SEND BACK. PROCODE: QLG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1935401 | LIBRE BLOOD SUGAR MONITOR | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE | QLG | ABBOTT DIABETES CARE INC. | |||
| 517602 | LIBRE BLOOD SUGAR MONITOR | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE | QLG | ABBOTT DIABETES CARE INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | ANXIETY, | ANXIETY, | DEPRESSION, | DEPRESSION, | HIGH BLOOD PRESSURE,| HIGH BLOOD PRESSURE,| MEDS FOR DIABETICS,| MEDS FOR DIABETICS,| NEUROPATHY, MORE| NEUROPATHY, MORE| PACEMAKER, | PACEMAKER, | SCIATICA, | SCIATICA, | |
| 1 | 57 YR | Male | ANXIETY, | ANXIETY, | DEPRESSION, | DEPRESSION, | HIGH BLOOD PRESSURE,| HIGH BLOOD PRESSURE,| MEDS FOR DIABETICS,| MEDS FOR DIABETICS,| NEUROPATHY, MORE| NEUROPATHY, MORE| PACEMAKER, | PACEMAKER, | SCIATICA, | SCIATICA, |