MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-28 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics.
[2572142]
Immulite 2000 growth hormone (grh) results were obtained on pediatric patient samples. The results were reported to the physician(s). The physician expected peak results at approximately 10 ng/ml. There were no reports of patient intervention or adverse health consequences due to the discordant growth hormone results.
Patient Sequence No: 1, Text Type: D, B5
[9751200]
A siemens global product support (gps) evaluated the immulite 2000 instrument data and determined that the instrument is performing with specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00089 |
| MDR Report Key | 2507315 |
| Report Source | 05,06 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-03-12 |
| Date of Event | 2012-02-01 |
| Date Mfgr Received | 2012-03-12 |
| Date Added to Maude | 2012-09-06 |
| 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 | 0 |
| Manufacturer Contact | ELIZABETH BEATO |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243074 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS |
| Manufacturer City | CAENAFON, GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNOASSAY ANALYZER, |
| Product Code | CFL |
| Date Received | 2012-03-28 |
| Model Number | IMMULITE 2000 |
| Lot Number | 122 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | LLANBERRIS GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-28 |