MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[38539951]
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
[38539952]
On (b)(6) 2016, it was reported that on the first dose, the buttons were " sticky" and then stayed in the locked position. The patient was said to have replaced the patch with a new one, and dose was delivered without issue. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the device was unable to deliver insulin.
Patient Sequence No: 1, Text Type: D, B5
[42301892]
Follow-up #1 04/06/2016 device evaluation: the inserter has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: the patch showed evidence that the device was filled, partially debubbled and deployed. The patch buttons were not locked per the allegation upon receipt of the product. During testing the device was clicked several times without issues. The button travel was not found to be hindered or sticking during testing. There was no foreign material noted on the patch and there was no damage to the buttons, casing, or any of the springs. The cannula appeared slightly bent during investigation however this appeared to be related to lack of protection during shipping. The alleged sticking button allegation was unable to be confirmed or duplicated during testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008272700-2016-00007 |
| MDR Report Key | 5426839 |
| Date Received | 2016-02-10 |
| Date of Report | 2016-01-29 |
| Date Mfgr Received | 2016-01-29 |
| Date Added to Maude | 2016-02-10 |
| 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 | 2016-02-10 |
| 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 | 2016-02-10 |
| 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 | 2016-02-10 |