MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-01-13 for MULTISTIX 10SG STRIPS 10627148 manufactured by Siemens Healthcare Diagnostics Inc.
[4090762]
Customer reported 27 false positive urobilinogen results using deteriorated multistix 10sg test strips. Customer indicated that they have been running patient samples on these test strips since (b)(6) 2013. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11538313]
Customer indicated that they run patient samples even when the quality control (qc) failed. Customer should not have run the patient samples when qc was failed. Customer has been provided with new bottle of multistix 10sg strips. Customer indicated that the issue is resolved with a new lot of multistix 10sg strips. The event has occurred due to an operator error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00260 |
| MDR Report Key | 3601616 |
| Report Source | 07 |
| Date Received | 2014-01-13 |
| Date of Report | 2013-12-20 |
| Date of Event | 2013-11-25 |
| Date Mfgr Received | 2013-12-20 |
| Date Added to Maude | 2014-03-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | KIMBELL ELECTRONICS POLAND SP. Z O O |
| Manufacturer Street | UI POZNANSKA 1/C |
| 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 STRIPS |
| Generic Name | MULTISTIX 10SG |
| Product Code | JIO |
| Date Received | 2014-01-13 |
| Catalog Number | 10627148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-13 |