MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-22 for MULTISTIX 10SG STRIPS 10627148 manufactured by Siemens Healthcare Diagnostics Inc..
[4113003]
Customer reported 1+ to 2+ white blood cell results on the multistix strip visually whereas microscopic result was large for the white blood cells. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11310630]
One bottle of the multistix 10 sg from the customer was returned for investigation. No sample from the pt was provided. Siemens technical operations completed their testing but were unable to confirm the customers observations. The cause for the discordant white blood cell result is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00222 |
| MDR Report Key | 3535810 |
| Report Source | 07 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-11-01 |
| Date of Event | 2013-09-15 |
| Date Mfgr Received | 2013-11-01 |
| Date Added to Maude | 2014-01-09 |
| 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 |
| 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. POZNZNSKA 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 | 2013-11-22 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-22 |