MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-09 for FREESTYLE LANCING DEVICE II 71582-01 manufactured by Abbott Diabetes Care Inc.
[182560300]
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. 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
[182560301]
Customer reported the eject mechanism on her adc lancing device does not eject lancets and she was therefore unable to check her blood glucose. Customer further reported that she was rushed to the emergency hospital because of this issue and received treatment with insulin (unknown dose). No further information was provided as the customer declined to continue troubleshooting and attempts to gather additional information has thus far been unsuccessful. There was no report of death or permanent impairment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-01905 |
| MDR Report Key | 9805954 |
| Report Source | CONSUMER |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2020-02-26 |
| Date Added to Maude | 2020-03-09 |
| 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 | 2020-03-09 |
| 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 | 2020-03-09 |