MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-24 for FREESTYLE II 71582-01 manufactured by Abbott Diabetes Care Inc.
[180822240]
At this time the lancing device body/barrel issue and determined that there was no indication that the product did not meet specification. No product was returned for this complaint and valid serial or lot number was not provided. The available tripped trend reports were reviewed for ld-2 and lancing device were completed. The review did not identify any trends that would indicate any product related issues related to this complaint. 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
[180822241]
A customer reported the adc freestyle lancing device ii "split-open" when attempting use. The customer was unable to use her lancing device and on (b)(6) 2020, she experienced "shaking and leg pain" and was unable to treat themselves. The customer went to the emergency room and a blood glucose of 58 mg/dl was obtained on the hospital meter and the customer was treated by the hcp with apple juice for hypoglycemia and had their blood glucose monitored. There was no report of death or permanent injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-01517 |
| MDR Report Key | 9747264 |
| Report Source | CONSUMER |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2020-02-11 |
| Date Added to Maude | 2020-02-24 |
| 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 II |
| Generic Name | LANCING DEVICE |
| Product Code | FMK |
| Date Received | 2020-02-24 |
| 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 | 2020-02-24 |