MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,study report with the FDA on 2016-01-25 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[36779167]
Calibra has been unable to request return of the product at this time. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[36779168]
On (b)(6) 2016 it was reported that the patient's blood glucose was 184mg/dl with no signs or symptoms of hyperglycemia after taking a dose of insulin from the device. There was no medical intervention; the patient replaced the device with a new one, dosed with insulin, and hyperglycemia resolved. This hyperglycemic incident does not meet the definition of an adverse event. It was said that when the patient removed the device from the skin, the cannula was bent. This complaint is being reported because the device was unable to deliver insulin due to a bent cannula.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2016-00006 |
| MDR Report Key | 5388877 |
| Report Source | CONSUMER,STUDY |
| Date Received | 2016-01-25 |
| Date of Report | 2016-01-20 |
| Date Mfgr Received | 2016-01-20 |
| Date Added to Maude | 2016-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SAM CRAWFORD |
| Manufacturer Street | 220 SAGINAW DR |
| Manufacturer City | REDWOOD CITY CA 940634725 |
| Manufacturer Country | US |
| Manufacturer Postal | 940634725 |
| Manufacturer Phone | 6502984705 |
| Manufacturer G1 | CALIBRA MEDICAL, INC |
| Manufacturer Street | 220 SAGINAW DR |
| Manufacturer City | REDWOOD CITY CA 940634725 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 940634725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | OPP |
| Date Received | 2016-01-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CALIBRA MEDICAL, INC |
| Manufacturer Address | 220 SAGINAW DR REDWOOD CITY CA 940634725 US 940634725 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-25 |