MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-14 for FREESTYLE LANCING DEVICE II 71582-01 manufactured by Abbott Diabetes Care Inc.
[180102794]
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. A tripped trend review was conducted for the reported complaint and lancing device, no trends were identified that would indicate any product related issues. If the product is returned, the case will be re-opened and a physical investigation will be performed. The device manufacturing 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
[180102795]
The customer reported that her adc lancing device separated on (b)(6) 2020. The customer attempted to continue to use the device, but reported the device would keep separating. The customer had no symptoms prior to losing consciousness while sleeping, and was taken to a hospital on (b)(6) 2020. The customer was diagnosed with hypoglycemia, and treated with glucose via injection. There was no report of death or permanent injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-01293 |
| MDR Report Key | 9714424 |
| Report Source | CONSUMER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2020-01-31 |
| Date Added to Maude | 2020-02-14 |
| 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 LANCING DEVICE II |
| Generic Name | LANCING DEVICE |
| Product Code | FMK |
| Date Received | 2020-02-14 |
| Model Number | 71582-01 |
| 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. Required No Informationntervention | 2020-02-14 |