MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-10-06 for MULTISTIX 8 SG REAGENT STRIPS FOR URINALYSIS 10320335 manufactured by Siemens Healthcare Diagnostics.
[89722081]
The reagent has been requested to be returned for investigation. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[89722082]
The customer reported a false negative leukocyte and bacteria on the multistix 8 sg reagent strips for urinalysis, read visually, when compared to the microscopic exam of the sediment. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2017-00135 |
| MDR Report Key | 6921887 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-10-06 |
| Date of Report | 2018-02-27 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2017-10-06 |
| 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 | 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 | 3 |
| Brand Name | MULTISTIX 8 SG REAGENT STRIPS FOR URINALYSIS |
| Generic Name | MULTISTIX 8 SG |
| Product Code | JIR |
| Date Received | 2017-10-06 |
| Catalog Number | 10320335 |
| Lot Number | 702038 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-06 |