MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2015-07-17 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[6431875]
On (b)(6) 2015 the reporter contacted calibra indicating that the patch was filled as normal but prior to inserting the patch, insulin was noted to have leaked out. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[14033745]
The product has not been returned to calibra. 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
[23559426]
Follow up #1: additional information: calibra contacted the patient on (b)(6) 2015 for additional troubleshooting of the reported event. The reporter indicated that the device was filled with 200 units of insulin. During the prime step the patient indicated holding the device vertical out in front of the body and pressed the buttons until the device clicked 3 times to prime, but the device was noted to be leaking from an area other than the cannula at that time. The patient confirmed feeling that he received the proper training.
Patient Sequence No: 1, Text Type: N, H10
[28660888]
Follow-up #2 09/08/2015 device evaluation: the patch has been returned and evaluated by product analysis on 08/31/2015 with the following findings: the finesse patch was examined. The insulin reservoir was found to have an air bubble present. The fill septum appeared normal. The guide cap was found to have excess insulin in the insulin trap fins and the liner was found to have insulin around the guide cap possibly indicating that the device was clicked many times. When the beige cap was removed, no residual insulin was found, the welds were confirmed competent, and the reservoir bonds were in excellent condition confirming no internal leaks. During testing, the device de-bubbled with 5 clicks. The device clicked 47 times until the last dose lock out delivering approximately 94 units. The product was within specifications and performed appropriately during testing. Lot record review of all lots released for the market acceptance study was completed and lots were found to be operating within required specifications at the time of release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008272700-2015-00020 |
| MDR Report Key | 4921775 |
| Report Source | 04,CONSUMER |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-10 |
| Date Mfgr Received | 2015-07-10 |
| Date Added to Maude | 2015-08-06 |
| 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 | 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 | 2015-07-17 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-07-17 |