MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-25 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[20751097]
Discordant alpha fetoprotein (afp), antithyroid peroxidase antibodies (ata), dehydroepiandrosterone sulfate (dhea-so4), homocysteine (hcy), helicobater pylori igg (hpg), cancer antigen marker (ca-125), sex hormone-binding globulin (shbg), testosterone (tes), thyroglobulin (tg) and the customer's calculated free testosterone (tesfc) results were obtained on multiple patient samples on an immulite 2000 instrument. The discordant results were reported to the physician(s). After troubleshooting, the samples were repeated on the same instrument, resulting different from the initial results. The corrected results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant afp, ata, dhea-so4, hcy, hpg, shbg, ca-125, tes, tg and tesfc results.
Patient Sequence No: 1, Text Type: D, B5
[21040200]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse discovered that the reagent dual resolution dilutor (drd) was broken. The cse replaced and adjusted the drd and the valves and ran the water test, which was acceptable. The customer ran quality controls, which were within acceptable ranges. The cause of the discordant afp, ata, dhea-so4, hcy, hpg, shbg, ca-125, tes, tg and tesfc results on multiple patient samples was related to the broken reagent drd. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00038 |
| MDR Report Key | 4867922 |
| Report Source | 05,06 |
| Date Received | 2015-06-25 |
| Date of Report | 2015-06-01 |
| Date of Event | 2015-05-28 |
| Date Mfgr Received | 2015-06-01 |
| Date Added to Maude | 2015-07-21 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 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 | DGC |
| Date Received | 2015-06-25 |
| Model Number | IMMULITE 2000 |
| 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 | 2015-06-25 |