MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-04 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics.
[15779413]
Imprecision was observed on four patient samples for insulin-like growth factor (igf-1) on an immulite 2000 instrument. It is unknown whether patient samples were reported to the physician(s). There were no reports of patient intervention or adverse health consequences due to the imprecision on the four patient samples.
Patient Sequence No: 1, Text Type: D, B5
[15804201]
A siemens global product support (gps) specialist evaluated the instrument data, and could not find an instrument malfunction. A siemens field service engineer (fse) was dispatched to the customer site. The fse evaluated the instrument and instrument data, and also could not find an instrument malfunction. The fse performed preventive maintenance and proactively replaced spare parts. The cause of the igf-1 imprecision is unknown. This instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2013-00023 |
| MDR Report Key | 2988263 |
| Report Source | 05,06 |
| Date Received | 2013-03-04 |
| Date of Report | 2013-02-05 |
| Date of Event | 2013-01-29 |
| Date Mfgr Received | 2013-02-05 |
| Date Added to Maude | 2013-05-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| 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 | OAM |
| Date Received | 2013-03-04 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 030002 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-04 |