MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-02-16 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[18641930]
Discordant human chorionic gonadotropin (hcg) results were obtained on two patient samples on an immulite 2000 instrument. The discordant results were reported to the physician(s). The samples were repeated on the same system. The corrected hcg results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant hcg results.
Patient Sequence No: 1, Text Type: D, B5
[18936926]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse analyzed the instrument and instrument data and determined the substrate pump was not dispensing the correct fluid volume. The cse replaced the substrate pump and validated the correct fluid volume dispense. The customer successfully ran quality controls. The cause of the discordant hcg results is due to a substrate pump malfunction. The system is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00005 |
| MDR Report Key | 4519800 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-16 |
| Date of Report | 2015-01-22 |
| Date of Event | 2015-01-20 |
| Date Mfgr Received | 2015-01-22 |
| Date Added to Maude | 2015-03-19 |
| 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 | JOHN NELSON |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD FLANDERS |
| Manufacturer City | 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 | IMMUNOASSAY ANALYZER |
| Product Code | JJQ |
| Date Received | 2015-02-16 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 30002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-16 |