MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-26 for ADVIA 2400 manufactured by Siemens Healthcare Diagnostics Inc..
[76077844]
The customer called a siemens technical support technician (tst) to report the discordant ammonia results. Initially, the customer obtained a negative, out of range quality controls (qc) result. The customer repeated qc with the same cup and it resulted in range. A siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced all l-rings, cleaned the reaction cuvette washer wud and oil bath, and replaced all fluids. The cse ran samples without any problem. The cause of the discordant ammonia results is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[76077845]
Discordant ammonia results were obtained on patient samples on an advia 2400 instrument. The discordant results were not reported to the physician(s). The samples were repeated on the same instrument resulting within the expected range. The corrected results were not provided to physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant ammonia results.
Patient Sequence No: 1, Text Type: D, B5
[86863970]
The initial mdr 2432235-2017-00339 was filed on may 26, 2017. Corrected information (06/07/2017): there were no discordant patient results. The discrepancy was obtained only on quality controls.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00339 |
| MDR Report Key | 6594057 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-26 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-04-29 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-05-26 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | 3-1-2 MUSASHINO AKISHIMA REGISTRATION#: 3003637681 |
| Manufacturer City | TOKYO, 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2400 |
| Generic Name | ADVIA 2400 |
| Product Code | JIF |
| Date Received | 2017-05-26 |
| Model Number | ADVIA 2400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-05-26 |
| Model Number | ADVIA 2400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-05-26 |