MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-03-08 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[69444535]
The customer contacted a siemens customer care center and stated that their quality controls were out of range. The customer performed calibration and reran quality controls, which were acceptable. The customer also determined that the patient results were elevated when quality controls were elevated and low when quality controls were low. The water purification system attached to the advia 2400 instrument uses a glycerol based lubricant to fit in the reverse osmosis membranes, which contaminated the water causing trig_2c to be discordant. When the customer performed calibration the quality controls factored in and came back to normal. The water purification company was contacted by the customer to resolve the issue. The cause of the discordant tric_2c results on multiple patient samples was due to the contamination of water purification system. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[69444536]
The customer obtained discordant concentrated triglyceride (trig_2c) results on multiple patient samples on an advia 2400 instrument. The discordant results were reported to the physician(s). The samples were repeated on the same instrument, resulting different from the initial results. The corrected results were reported to the physician(s). Some of the samples were discarded by the sample storage module and therefore no samples were available for repeat testing. It is unknown if the new samples were obtained for those patients and if the repeat results were reported to the physician(s). There are no reports of any impact on patient intervention or adverse health consequences due to the discordant trig_2c results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00170 |
| MDR Report Key | 6389240 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-08 |
| Date of Report | 2017-03-08 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-02-13 |
| Device Manufacturer Date | 2014-09-19 |
| Date Added to Maude | 2017-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO 96-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 96-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | JGY |
| Date Received | 2017-03-08 |
| Model Number | ADVIA 2400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | JJE |
| Date Received | 2017-03-08 |
| Model Number | ADVIA 2400 |
| 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 | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-08 |