MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-14 for MULTISTIX 10SG STRIPS 10627148 manufactured by Siemens Healthcare Diagnostics Inc..
[4183603]
Customer reported negative nitrite and leukocytes results on the instrument whereas culture results were positive for both analytes. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11626475]
Customer is being requested to send reagent back for further investigation. Customer indicated that they are not currently using siemens test strips. The cause for the discordant results is unknown.
Patient Sequence No: 1, Text Type: N, H10
[33325902]
The initial mdr 1217157-2014-00020 was filed with fda on february 14, 2014. Additional information: based on the additional information, siemens technical operations tested customer's returned reagent and could not confirm complaint. As per the modern urine chemistry manual, "a negative nitrite should never be interpreted as indicating an absence of bacteriuria. There are several reasons for this. First-morning urine, or urine that has remained in the bladder for four or more hours, is mor likely to yield a positive nitrite test result in the presence of significant bacteriuria than a random urine sample that have been in the bladder only a short time. In the latter type of specimen, there may have been insufficient time for the conversion of nitrate to nitrite by the infecting bacteria. Some strains of urinary pathogens do not produce the enzyme necessary to reduce nitrate to nitrite, but thes organisms are the least common pathogens. A negative test result may also occur if dietary nitrates are absent. " customer has been provided with a replacement bottle of reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00020 |
| MDR Report Key | 3649068 |
| Report Source | 07 |
| Date Received | 2014-02-14 |
| Date of Report | 2014-01-17 |
| Date of Event | 2014-01-15 |
| Date Mfgr Received | 2014-01-17 |
| Date Added to Maude | 2014-03-04 |
| 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 |
| 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 | 2014-02-14 |
| 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 | 2014-02-14 |