MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for IMMULITE 2000 SYPHILIS SCREEN L2KSY2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[99793344]
A siemens headquarters support center specialist reviewed the instrument data and did not find any level sense issues or bubbles. The cause of the (b)(6) result on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[99793345]
A discordant, (b)(6) result was obtained on one patient sample on an immulite 2000 xpi instrument, while using kit lot 312. The discordant result was not reported to the physician(s). The sample was repeated neat and with dilution factor 1:2, resulting reactive both times. The sample was also tested using other methodologies, resulting reactive. The reactive results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, (b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00045 |
| MDR Report Key | 7245053 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-04-02 |
| Date Added to Maude | 2018-02-06 |
| 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 | 3 |
| Manufacturer Contact | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMMULITE 2000 SYPHILIS SCREEN |
| Generic Name | IMMULITE 2000 SYPHILIS SCREEN |
| Product Code | LIP |
| Date Received | 2018-02-06 |
| Model Number | IMMULITE 2000 SYPHILIS SCREEN |
| Catalog Number | L2KSY2 |
| Lot Number | 312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-06 |