MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-09 for IMMULITE 2000 HERPES I & II L2KHVG manufactured by Siemens Healthcare Diagnostics, Inc..
[1103275]
Customer reported discordant immulite 2000 (b)(6) qualitative assay result obtained on a patient sample using cerebral spinal fluid (csf) as sample type. Initial and repeated results were indicated as nonreactive. The customer established its own method for csf sample type with nonreactive value result to be multiplied by 4. 3 and review against the reference range. Csf sample type is not recommended to use on this assay and customer practice of re-interpreting the result is not supported by manufacturer ifu. It's unk whether patient treatment were altered and no indication of patient treatment administered. Patient treatment is unk and there was no report of adverse health consequences due to customer off-label usage of the (b)(6) assay.
Patient Sequence No: 1, Text Type: D, B5
[8438821]
A siemens field service engineer (fse) was sent to the customer site. Analysis of instrument and instrument data didn't indicate system error. The instrument is performing within specifications. No further evaluation of the device is required. It has been communicated to the customer that use of csf for this assay is outside of the product intended use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017183-2009-00010 |
| MDR Report Key | 1408898 |
| Report Source | 05 |
| Date Received | 2009-03-09 |
| Date of Report | 2009-02-11 |
| Date of Event | 2009-02-05 |
| Date Mfgr Received | 2009-02-11 |
| Date Added to Maude | 2010-10-01 |
| 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 | STEVEN ANDBERG |
| Manufacturer Street | 5210 PACIFIC CONCOURSE |
| Manufacturer City | LOS ANGELES CA 900455597 |
| Manufacturer Country | US |
| Manufacturer Postal | 900455597 |
| Manufacturer Phone | 5086608540 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 5700 W. 96TH STREET |
| Manufacturer City | LOS ANGELES CA 90045559 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90045 5597 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 HERPES I & II |
| Generic Name | HERPES I & II IGG IMMUNOASSAY |
| Product Code | GQL |
| Date Received | 2009-03-09 |
| Model Number | NA |
| Catalog Number | L2KHVG |
| Lot Number | 216 |
| ID Number | NA |
| Device Expiration Date | 2009-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | LOS ANGELES CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-09 |