MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-27 for NET TEST * 40-1173 manufactured by Remel.
[18479829]
A gonorrhea culture received in the lab on 3/14/98. It was plated out according to lab policy. The next day the culture was read as a positive neisseria gonorrhea with moderate growth or gram negative diplococci. The isolate was tested with the net testing kit. Controls were set up along with the test specimen. The test was performed according to testing procedure. The test reagent turned red which is interpreted as n. Gonorrhae. The test was repeated and the results were the same. The culture was sent for confirmation, when the results were received, the net test was repeated by a second technologist and the results were the same as the first testing. When the culture was sent out for confirmation the results were negative for n. Gonorrhea. On 3/24/98 the specimen was tested with a new lot of net and the specimen was identified as neisseria meningitidis. The specimen was repeated a third time with the first kit and also was identified as n. Meningitidis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 161055 |
| MDR Report Key | 161055 |
| Date Received | 1998-03-27 |
| Date of Report | 1998-03-26 |
| Date of Event | 1998-03-14 |
| Date Facility Aware | 1998-03-23 |
| Report Date | 1998-03-26 |
| Date Reported to Mfgr | 1998-03-23 |
| Date Added to Maude | 1998-04-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NET TEST |
| Generic Name | LABORATORY TESTING KIT FOR IDENTIFICATION OF N. GONORRHEA |
| Product Code | JSX |
| Date Received | 1998-03-27 |
| Model Number | * |
| Catalog Number | 40-1173 |
| Lot Number | 230052 |
| ID Number | * |
| Device Expiration Date | 1998-05-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 156835 |
| Manufacturer | REMEL |
| Manufacturer Address | 12076 SANTE FE DRIVE LENEXA KS 662153594 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-27 |