MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-12-26 for IMMULITE 2000 XPI 030001-03 manufactured by Siemens Healthcare Diagnostics Inc..
[5233929]
The customer has obtained a false negative result on one patient sample for syphilis on an immulite 2000 xpi instrument. The result was reported to the physician who questioned the result and requested a retest of the sample. The sample was repeated on another immulite 2000 xpi instrument and the result was positive. This result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the false negative syphilis result.
Patient Sequence No: 1, Text Type: D, B5
[12625527]
A siemens headquarters support specialist (hsc) reviewed the instrument files. Since the time the discordants were obtained on the immulite 2000 xpi, the customer has installed a new immulite 2000 xpi. As a result the instrument files during the time the false negative result was obtained could not be evaluated. Based on the instrument files received hsc did inform the customer that multiple samples were tested for syphilis at the same time the false negative was obtained on the one patient sample. The other samples were not reported as discordants. The cause of the false negative result on the patient sample is unknown. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2014-00092 |
| MDR Report Key | 4362484 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-26 |
| Date of Report | 2014-12-10 |
| Date of Event | 2014-11-14 |
| Date Mfgr Received | 2014-12-10 |
| Date Added to Maude | 2015-01-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | JJQ |
| Date Received | 2014-12-26 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-03 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-26 |