MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-02 for ANIMAS VIBE manufactured by Animas Corporation.
[90885990]
The device has not been returned to animas for evaluation. If the device is returned, an evaluation shall be completed and a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[90885991]
On (b)(6) 2017, a reporter contacted animas alleging that a patient had experienced a hypoglycemic event while on the pump. The reporter stated that the patient was uncertain what blood glucose they had, but that emergency services were called. The patient was reportedly? Out of it? And treated with intravenous fluids and glucagon. The reporter stated that the patient had altered the pump? S basal settings prior to the event. This complaint is being reported based on the allegation that the patient experienced a hypoglycemic event as a result of adjusting the pump? S basal rates.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2531779-2017-25636 |
| MDR Report Key | 6996383 |
| Report Source | CONSUMER |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-10 |
| Date Mfgr Received | 2017-10-10 |
| Device Manufacturer Date | 2017-08-25 |
| Date Added to Maude | 2017-11-02 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARIN SARGRAD |
| Manufacturer Street | 200 LAWRENCE DR |
| Manufacturer City | WEST CHESTER PA 193803428 |
| Manufacturer Country | US |
| Manufacturer Postal | 193803428 |
| Manufacturer Phone | 4843561808 |
| Manufacturer G1 | ANIMAS CORPORATION |
| Manufacturer Street | 200 LAWRENCE DR |
| Manufacturer City | WEST CHESTER PA 193803428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 193803428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANIMAS VIBE |
| Generic Name | INSULIN INFUSION PUMP |
| Product Code | OYB |
| Date Received | 2017-11-02 |
| ID Number | 1-MCBC-3762 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANIMAS CORPORATION |
| Manufacturer Address | 200 LAWRENCE DR WEST CHESTER PA 193803428 US 193803428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-11-02 |