MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-11-09 for CLINITEK STATUS manufactured by Siemens Healthcare Diagnostics.
[2952777]
False negative white blood cells on mas qc control and patient with multistix 10 sg. Customer stated that it is unknown if patient care was delayed/impacted as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[10230683]
Customer reports that quality control lots being used are within their expiration dating. Routine exam of the instrument was performed. Calibration bar was checked for discoloration, scratches or damage. Quality control strips were changed to a new lot. Calibration bar and test table were cleaned with distilled water. Customer was sent a customer bulletin on recommended controls for use as customer was using mas controls which are not recommended. Customer was told to monitor the results for further false negative results. They were further advised to perform a visual read-do not look at the testing strip to determine if the sample is negative or positive. In addition, they were advised to dip the strip setting the timer at the same time, rim the strip and read the leukocyte at the two minute mark.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2012-00058 |
| MDR Report Key | 2860281 |
| Report Source | 07 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-11 |
| Date of Event | 2012-10-11 |
| Date Mfgr Received | 2012-10-11 |
| Date Added to Maude | 2012-12-21 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | NORTHERN ROAD |
| Manufacturer City | SUDBURY, SUFFOLK CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINITEK STATUS |
| Generic Name | CT STATUS |
| Product Code | JJW |
| Date Received | 2012-11-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-11-09 |