MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-02-05 for CLINITEK 500 CT 500 manufactured by Siemens Healthcare Diagnostics.
[3354957]
Customer reports they are performing correlations from iris to ct500 and have found leukocytes are under recovering on the ct500. There was no report of injury with the event.
Patient Sequence No: 1, Text Type: D, B5
[10562400]
Customer states that at least 2 different lot numbers of reagents have been used and that microscopic exams are done on all positive leukocyte results. Customer will also perform another correlation study making sure testing is done on fresh samples. The cause of the unrecovered leukocytes is not known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2013-00011 |
| MDR Report Key | 2997224 |
| Report Source | 07 |
| Date Received | 2013-02-05 |
| Date of Report | 2012-12-13 |
| Date of Event | 2012-12-13 |
| Date Mfgr Received | 2012-12-13 |
| Date Added to Maude | 2013-04-19 |
| 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 | MARK SMITH |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693158 |
| Manufacturer G1 | HEALTHCARE DIANGOSTICS MFG LTD. |
| Manufacturer Street | NORTHERN ROAD |
| Manufacturer City | SUBDBURY, SUFFOLK CO102X |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2X |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK 500 |
| Generic Name | CLINITEK 500 |
| Product Code | CDM |
| Date Received | 2013-02-05 |
| Model Number | CT 500 |
| 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 |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-05 |