MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-11-24 for IMMULITE 2000 RUBELLA IGG L2KRUB manufactured by Siemens Healthcare Diagnostics Inc..
[18514880]
A low positive immulite 2000 rubella igg assay result was obtained on a pregnant patient sample. Multiple retesting of the patient sample resulted in higher result values. The low rubella igg result was reported to the physician. Patient treatment was not altered and there was no report of adverse health consequences due to the discordant low rubella igg assay result.
Patient Sequence No: 1, Text Type: D, B5
[18692585]
Analysis of the instrument and instrument data indicate that the cause for the discordant rubella igg result is unknown. It's suspected that customer did not use the recommended tube on the initial sample result. No further evaluation of the device is required. The instrument is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017183-2008-00052 |
| MDR Report Key | 1278487 |
| Report Source | 05 |
| Date Received | 2008-11-24 |
| Date of Report | 2008-09-17 |
| Date of Event | 2008-05-14 |
| Date Mfgr Received | 2008-09-17 |
| Date Added to Maude | 2010-04-08 |
| 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 WEST 96TH ST. |
| 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 RUBELLA IGG |
| Generic Name | RUBELLA IGG IMMUNOASSAY |
| Product Code | DGC |
| Date Received | 2008-11-24 |
| Model Number | NA |
| Catalog Number | L2KRUB |
| Lot Number | 250 |
| ID Number | NA |
| Device Expiration Date | 2008-08-31 |
| 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 | 2008-11-24 |