MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-21 for FINESSE PATCH manufactured by Calibra Medical, Inc.
[73667038]
The product is not being returned as the device has been discarded. The lots were manufactured, inspected, and released per approved calibra procedures. No issues related to the complaint were identified during the processing of the lots. No conclusions can be made at this time. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73667039]
On (b)(6) 2017, it was reported that the buttons did not lock when the device was empty. The patient said that it only happened with one device. The following sequence of events was reported: it was the last day of use and the patient was ready to change the device. He delivered a breakfast bolus; the buttons did not lock at the end of the dose. He took off the device and said it looked empty. He clicked it in the air several times to empty the device but nothing came out. At the end of his test, the buttons never locked. The patient reported that he did not experience a noticeable blood glucose excursion. This complaint is being reported because the issue may cause lack of insulin delivery without patient awareness due to device not detecting an empty reservoir.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272700-2017-00011 |
| MDR Report Key | 6510983 |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-12 |
| Date Mfgr Received | 2017-04-12 |
| Date Added to Maude | 2017-04-21 |
| 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 | 965 CHESTERBROOK BLVD |
| Manufacturer City | WAYNE PA 19087 |
| Manufacturer Country | US |
| Manufacturer Postal | 19087 |
| Manufacturer Phone | 4843561808 |
| Manufacturer G1 | CALIBRA MEDICAL, INC |
| Manufacturer Street | 965 CHESTERBROOK BLVD |
| Manufacturer City | WAYNE PA 19087 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19087 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FINESSE PATCH |
| Generic Name | FINESSE INSULIN DELIVERYSYSTEM |
| Product Code | OPP |
| Date Received | 2017-04-21 |
| Lot Number | 400 |
| ID Number | 1-2VSIX7R |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CALIBRA MEDICAL, INC |
| Manufacturer Address | 965 CHESTERBROOK BLVD WAYNE PA 19087 US 19087 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-21 |