MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for FREESTYLE LIBRE 14 DAY 71937-01 71937 manufactured by Abbott Diabetes Care Inc.
[185146552]
The product has been requested back for an investigation. A follow-up report will be submitted once additional information is obtained. The date of event 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
[185146553]
Customer reported the adc freestyle libre reader was exposed to moisture and was not powering on with button press or test strip and therefore she was unable to test. Customer further reported she had contact with healthcare provider and an unspecified high reading was obtained on an unspecified meter. Customer received unspecified treatment from her hcp. No further information was provided as the call was disconnected by the customer during troubleshooting. There was no report of death or permanent impairment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[187478699]
No product has 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 libre reader were reviewed and the dhrs showed the 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. This also serves as a correction report. Model number was incorrectly documented in the initial report. The correct model number has been updated.
Patient Sequence No: 1, Text Type: N, H10
[187478700]
Customer reported the adc freestyle libre reader was exposed to moisture and was not powering on with button press or test strip and therefore she was unable to test. Customer further reported she had contact with healthcare provider and an unspecified high reading was obtained on an unspecified meter. Customer received unspecified treatment from her hcp. No further information was provided as the call was disconnected by the customer during troubleshooting. There was no report of death or permanent impairment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-02324 |
| MDR Report Key | 9884349 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-24 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | 2020-03-26 |
| Model Number | 71937-01 |
| Catalog Number | 71937 |
| 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. Required No Informationntervention | 2020-03-26 |