MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-04 for MULTISTIX 10SG 10627148 manufactured by .
[32997457]
Customer has been requested to return multistix 10sg for investigation. The cause for the discordant nitrite result is unknown.
Patient Sequence No: 1, Text Type: N, H10
[32997458]
Customer reported false negative nitrite results when they read visually on multistix 10sg. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2015-00180 |
| MDR Report Key | 5267845 |
| Date Received | 2015-12-04 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-11-11 |
| Date Mfgr Received | 2015-11-11 |
| Date Added to Maude | 2015-12-04 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | KIMBALL ELECRONICS |
| Manufacturer Street | UL. POZENANSKA 1/C POLAND SP.Z O.O |
| Manufacturer City | TARNOWO PODGORNE, 62080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MULTISTIX 10SG |
| Generic Name | MULTISTIX 10SG |
| Product Code | JIR |
| Date Received | 2015-12-04 |
| Catalog Number | 10627148 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-04 |