MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-15 for COBAS PCR MEDIA DUAL SWAB SAMPLE KIT 07958021190 manufactured by Roche Molecular Systems, Inc..
[123678773]
In the packet- the two swabs both have a "black line. " this is confusing to staff, and staff places both swabs in the pcr media that results in the test being compromised and unable to be processed. Also, there are no clear directions on packaging to help mitigate this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7964648 |
| MDR Report Key | 7964648 |
| Date Received | 2018-10-15 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-10-10 |
| Report Date | 2018-10-11 |
| Date Reported to FDA | 2018-10-11 |
| Date Reported to Mfgr | 2018-10-15 |
| Date Added to Maude | 2018-10-15 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS PCR MEDIA DUAL SWAB SAMPLE KIT |
| Generic Name | DNA-REAGENTS, NEISSERIA |
| Product Code | LSL |
| Date Received | 2018-10-15 |
| Model Number | 07958021190 |
| Catalog Number | 07958021190 |
| Lot Number | E09933 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 4300 HACIENDA DRIVE PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-15 |