MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-03 for IMMULITE 2000 L2KHB manufactured by Siemens Healthcare Diagnostics Inc..
[21882515]
The customer obtained (b)(6) results on two patient samples for the (b)(6) when using reagent lot 696 on an immulite 2000 instrument. The customer also observed that quality control samples were running low or out of specification when using reagent lot 696. The patient samples were first run using reagent lot 696 and then repeated using reagent lot 695. The two patient samples were (b)(6) when tested using reagent lot 695. The (b)(6) results were reported to the physician(s). It is unknown if the (b)(6) results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to this event.
Patient Sequence No: 1, Text Type: D, B5
[22149527]
The cause of the (b)(6) results for (b)(6) on the immulite 2000 is unknown. Siemens diagnostics is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[38878833]
The initial mdr 2432235-2014-00255 was filed on april 3, 2014. The initial mdr was filed against the immulite 2000 (b)(6). Based on further investigations and service by siemens field service engineer (fse), it was determined that the immulite 2000 (b)(6) was performing as per specifications. Additional information (3/14/2014): a fse was dispatched to the customer site. After evaluation of the instrument, the fse replaced and adjusted probes, the dual resolution dilutor (drd) seals, and springs. In addition a routine preventative maintenance and a system decontamination was completed. (b)(6) adjustors and quality control samples were run on the instrument and recovered within specifications. The cause of the (b)(6) results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00255 |
| MDR Report Key | 3725038 |
| Report Source | 05,06 |
| Date Received | 2014-04-03 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-03-11 |
| Date Mfgr Received | 2014-03-14 |
| Date Added to Maude | 2014-05-30 |
| 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 | MS AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE 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 LLANBERIS CAERNARFON |
| 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 | CIZ |
| Date Received | 2014-04-03 |
| Model Number | IMMULITE 2000 |
| Catalog Number | L2KHB |
| Lot Number | 696 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 LLANBERIS, CAERNARFON FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-03 |