MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-21 for CLINITEK ATLAS ANALYZER 10309478 manufactured by Siemens Healthcare Diagnostics Inc.
[4447008]
Customer received false positives for urobilinogen on two patient samples. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11742530]
Siemens field service engineer(fse) went on site and checked the instrument. The instrument was having trouble calibrating and was stripping pads of the reagent roll. During fse inspection, reagent dispense mechanism was not locked properly into place which caused the pads to dispense improperly and strip pads off. Fse aligned the mechanism properly to which instrument passed calibration and controls. Instrument is operational on fse departure.
Patient Sequence No: 1, Text Type: N, H10
[32936212]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00073 |
| MDR Report Key | 3825108 |
| Report Source | 05 |
| Date Received | 2014-05-21 |
| Date of Report | 2014-04-22 |
| Date of Event | 2014-04-21 |
| Date Mfgr Received | 2014-05-27 |
| Date Added to Maude | 2014-06-27 |
| 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 | MR. STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SPARTON MEDICAL |
| Manufacturer Street | 22740 LUNN ROAD |
| Manufacturer City | CLEVELAND OH 44149 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44149 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK ATLAS ANALYZER |
| Generic Name | CT ATLAS |
| Product Code | CDM |
| Date Received | 2014-05-21 |
| Catalog Number | 10309478 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-05-21 |