MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for MULTISTIX 10 SG 10336425 manufactured by Siemens Healthcare Diagnostics.
[59895706]
The customer stated that the cause of the discrepant results was related to the lack of required customer maintenance and the issue is not occurring at this time. The customer also stated that repeat testing was performed to confirm correct results and a corrected report was issued.
Patient Sequence No: 1, Text Type: N, H10
[59895707]
The customer reported discrepant results between multistix 10 sg and when viewed under a microscope (40x magnification field) for urine blood, leukocytes and nitrites. There was no reported injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2016-00140 |
| MDR Report Key | 6089030 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-19 |
| Date Added to Maude | 2016-11-09 |
| 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 | 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 ELECTRONICS |
| 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 10 SG |
| Generic Name | MULTISTIX 10 SG |
| Product Code | JIR |
| Date Received | 2016-11-09 |
| Catalog Number | 10336425 |
| Lot Number | 604055 |
| Device Expiration Date | 2017-11-29 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-09 |