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 2015-05-15 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[18030724]
Discordant, false positive h. Pylori igg 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 an alternate immulite 2000 instrument, resulting negative. The corrected results were not reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, false positive h. Pylori results.
Patient Sequence No: 1, Text Type: D, B5
[18136569]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated that they received probe wash errors while running the patient samples. A siemens headquarters support center (hsc) specialist reviewed the instrument data and stated that the discordant results were consistent with the instrument running out of water. A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and tested the washing, the pipetting and the reading mechanisms. The cse could not find any instrument malfunction. The cse ran quality controls, which were within the acceptable ranges. The cause of the discordant, false positive h. Pylori igg results on two patient samples is unknown. 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 | 2247117-2015-00028 |
| MDR Report Key | 4775329 |
| Report Source | 01,05,06 |
| Date Received | 2015-05-15 |
| Date of Report | 2015-04-22 |
| Date of Event | 2015-04-17 |
| Date Mfgr Received | 2015-04-22 |
| Date Added to Maude | 2015-06-16 |
| 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 | LYR |
| Date Received | 2015-05-15 |
| 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 ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-15 |