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 2019-05-17 for CLINITEK ATLAS 10309478 manufactured by Siemens Healthcare Diagnostics.
[145424324]
The customer stated that repeat testing was performed to confirm correct results and a corrected report was issued. Siemens service went onsite. It was found that the redhead chassis was stained white due to age and spills. The redhead was replaced. The gespac was flushed and a significant amount of dust was removed. The gespac cpu board was replaced. The instrument passed a successful calibration and the qcs were in the expected ranges. The instrument is operational.
Patient Sequence No: 1, Text Type: N, H10
[145424325]
The customer reported a false negative urine leukocyte result on the clinitek atlas when compared to a visual dipstick read and a microscopic examination of the sediment. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2019-00060 |
| MDR Report Key | 8621112 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-04-24 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | FELIX AKINRINOLA |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 6107052212 |
| Manufacturer G1 | SPARTAN 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 |
| Generic Name | CLINITEK ATLAS |
| Product Code | KQO |
| Date Received | 2019-05-17 |
| Catalog Number | 10309478 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-05-17 |