MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-25 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[36936335]
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.
Patient Sequence No: 1, Text Type: N, H10
[36936336]
On (b)(6) 2016, it was reported that the button became locked on one side of the patch while the patient was delivering a dose of insulin. The patient mentioned that she might not have filled the patch sufficiently. Reportedly, this issue has not occurred since the patient was re-educated on filling the patch with more insulin. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because there is a possibility that the patch locked without reason, causing the device to become unusable.
Patient Sequence No: 1, Text Type: D, B5
[42639737]
Follow-up #1 04/12/2016 device evaluation: the patch has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: the two returned patches were found to have the buttons locked out. When the patch buttons are locked out, the valve button has a small amount of movement inward while the pump button is completely locked. During testing, the buttons were able to be released by injecting air into the reservoir and pressing the buttons. The patches were locked out again by pressing the buttons until they reached their last dose lockout. The patches were again confirmed to be able to unlock the buttons by injecting air into the reservoir. Based on the testing, it appears that the patch buttons were locked out due to reaching the last dose lockout.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008272700-2016-00004 |
| MDR Report Key | 5387785 |
| Date Received | 2016-01-25 |
| Date of Report | 2016-01-14 |
| Date Mfgr Received | 2016-01-14 |
| 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 | 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 | 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 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | LZG |
| Date Received | 2016-01-25 |
| Returned To Mfg | 2016-02-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| 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 |