MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-09-09 for MULTISTIX 10SG 10627148 manufactured by .
[54413539]
Siemens had requested to return the strips for further evaluation, no strips are being returned. Customer states that nothing is needed from siemens technical team. Customer does not want replacement strips because they do not require testing. Customer indicated that no further action is needed. Customer has requested no further contact regarding this issue.
Patient Sequence No: 1, Text Type: N, H10
[54413540]
Customer reported false negative protein 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 | 1217157-2016-00101 |
| MDR Report Key | 5939415 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-09-09 |
| Date of Report | 2016-09-09 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2016-08-10 |
| Date Added to Maude | 2016-09-09 |
| 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 |
| 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 | 3 |
| Brand Name | MULTISTIX 10SG |
| Generic Name | MULTISTIX 10SG |
| Product Code | JIR |
| Date Received | 2016-09-09 |
| Catalog Number | 10627148 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-09 |