MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-05-10 for MULTISTIX 8 SG 10627148 manufactured by Siemens Healthcare Diagnostics Inc..
[3443558]
Customer reported false negative results for leukocytes on multistix 8sg strips. There was no report of injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10783980]
The discordant results were due to operator error. Siemens investigation found that the site was using a non-siemens instrument to read the siemens multistix 8sg strips. As stated in the multistix 8sg ifu: siemens reagent strips are ready to use upon removal from the bottle and the entire reagent strip is disposable. The strips may be read visually, requiring no additional laboratory equipment for testing. The strips can also be read instrumentally, using the clinitek family of urine chemistry analyzers and the appropriate software.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00076 |
| MDR Report Key | 3163073 |
| Report Source | 07 |
| Date Received | 2013-05-10 |
| Date of Report | 2013-04-22 |
| Date of Event | 2013-04-03 |
| Date Mfgr Received | 2013-04-22 |
| Date Added to Maude | 2013-06-13 |
| 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 | PHARMACIST |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTISTIX 8 SG |
| Generic Name | MULTISTIX 8 SG |
| Product Code | JIO |
| Date Received | 2013-05-10 |
| Catalog Number | 10627148 |
| Lot Number | 207056 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-05-10 |