MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-18 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics, Inc..
[16422213]
A gps instrument support specialist reviewed the instrument files and found no indication of an instrument issue related to this false (b)(6) syphilis result. It was determined that the cause of the false (b)(6) syphilis result is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[16583726]
A false (b)(6) syphilis result on one patient sample was generated on the immulite 2000. The result was not reported to the physician. The same patient sample was re-tested (repeat) on the same instrument and a syphilis result was generated that was (b)(6). This result was not reported. There is no known report of adverse health consequences or patient intervention due to the false (b)(6) syphilis result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2011-00072 |
| MDR Report Key | 2342432 |
| Report Source | 05,06 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-10-26 |
| Date of Event | 2011-10-22 |
| Date Mfgr Received | 2011-10-26 |
| Date Added to Maude | 2011-11-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| 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 |
| Generic Name | IMMULITE 2000 |
| Product Code | JWL |
| Date Received | 2011-11-18 |
| Model Number | IMMULITE 2000 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH 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 | 2011-11-18 |