MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-23 for FREESTYLE LIBRE 14 DAY 71940-01 manufactured by Abbott Diabetes Care Inc.
[185901745]
At this time product has not yet been returned and a valid serial number has not been provided. An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification. Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits. Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality. Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field. Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field. Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint. A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues. Adc has made three attempts via phone as well as email to gather additional information and has been unsuccessful thus far, however additional attempts will be made. If the product is returned, a physical investigation will be performed and a follow-up report submitted. The device mfg date is unknown. The date entered is the date abbott diabetes care became aware of the event. All pertinent information available to abbott diabetes care has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[185901746]
Abbott diabetes care received a complaint from healthcare provider on (b)(6) 2020 in addition to the (b)(6) user reports received on (b)(6) 2020 and (b)(6) 2020, which contained the following information: customer experienced pain, a skin reaction and received low readings while wearing an adc freestyle libre sensor. Customer received unspecified low sensor readings. Customer's insertion site started to become erythematous with swelling and he experienced pain with symptoms of infection while wearing the sensor. Customer was feeling unwell, confused and condition deteriorated and the sensor was removed. Customer experienced "death like" situation and was hospitalized with suspected septicemia and necrotizing fasciitis that required surgery. It was further reported that customer experienced multiple organ failure following surgery and required treatment in intensive care. Sensor reading of "lo" (readings less than 40 mg/dl) was obtained compared to reading of 8 mmol/l (144 mg/dl) on an unspecified date. It was additionally reported that the customer remained in critically ill condition at the time of report and that it will be unlikely for patient to survive this episode. The doctors suspected that the event was due to sensors. No further information was reported and attempts to gather additional information has thus far been unsuccessful. There was no report of death or permanent injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-02268 |
| MDR Report Key | 9869437 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2020-03-09 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TARA WILLIAMSON |
| Manufacturer Street | 1360 SOUTH LOOP ROAD |
| Manufacturer City | ALAMEDA CA 945027001 |
| Manufacturer Country | US |
| Manufacturer Postal | 945027001 |
| Manufacturer Phone | 5108644472 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREESTYLE LIBRE 14 DAY |
| Generic Name | FLASH GLUCOSE MONITORING SYSTEM |
| Product Code | PZE |
| Date Received | 2020-03-23 |
| Model Number | 71940-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETES CARE INC |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 945027001 US 945027001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-23 |