MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-01-22 for CLINITEK 500 CT 500 manufactured by Siemens Healthcare Diagnostics.
[19731628]
Customer reports false negative leukocytes on instrument. When sample examine microscopically leukocytes are visible. No report of injury with the event.
Patient Sequence No: 1, Text Type: D, B5
[19837169]
Customer notes this is an intermittent problem. Biorad qc is run daily and results are within range. Customer was advised to continue to confirm results microscopically and visually. Customer advised on proper cleaning of the test table. Part number of new test table also provided if customer wishes to order new table. Manufacturer awaiting verification of improved results with new table or effectiveness of cleaning current table.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2012-00079 |
| MDR Report Key | 2962113 |
| Report Source | 07 |
| Date Received | 2013-01-22 |
| Date of Report | 2012-11-30 |
| Date of Event | 2012-11-30 |
| Date Mfgr Received | 2012-11-30 |
| Date Added to Maude | 2013-04-09 |
| 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 DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | NORTHERN ROAD |
| Manufacturer City | SUDBURY, 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 | LJX |
| Date Received | 2013-01-22 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-22 |