MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-08-29 for MEDI-JECT 100430-001 * manufactured by Medi-ject Corporation.
[89435]
User of medijector experienced a hyperglycemic episode which he related to partial insulin delivery due to cracked needle free syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182861-1997-00005 |
| MDR Report Key | 116429 |
| Report Source | 04 |
| Date Received | 1997-08-29 |
| Date of Report | 1997-07-31 |
| Date Mfgr Received | 1997-07-31 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1997-09-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDI-JECT |
| Generic Name | MEDIJECTOR CHOICE-NEEDLE FREE DELIVERY SYSTEM. |
| Product Code | EGM |
| Date Received | 1997-08-29 |
| Model Number | 100430-001 |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 114235 |
| Manufacturer | MEDI-JECT CORPORATION |
| Manufacturer Address | 161 CHESHIRE LANE MINNEAPOLIS MN 55441 US |
| Baseline Brand Name | MEDI-JECT |
| Baseline Generic Name | MEDIJECTOR CHOICE-NEEDLE FREE DELIVERY SYSTEM. |
| Baseline Model No | 100430-001 |
| Baseline Catalog No | * |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-29 |