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 2017-01-27 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[65967210]
A siemens technical support center specialist was dispatched to the customer site where he had run patient samples on the advia 1800 instrument (s/n (b)(4)) and the results were acceptable. The customer stated that the operator may have changed the samples. The cause of the discordant crp_2 results on two patient samples is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[65967211]
Discordant, falsely elevated c-reactive protein_2 (crp_2) results were obtained on two patient samples upon repeat testing on an advia 1800 instrument. The discordant results were reported to the physician(s). The samples were initially tested on an alternate advia chemistry instrument, resulting lower. A siemens technical application specialist was dispatched to the customer site where he repeated patient samples twice on the advia 1800 instrument (s/n (b)(4)) and the results were lower. The customer obtained new samples from both patients and tested them on the advia 1800 instrument (s/n (b)(4)), also resulting lower. 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, falsely elevated crp_2 results.
Patient Sequence No: 1, Text Type: D, B5
[73358468]
The initial mdr 2432235-2017-00088 was filed on january 27, 2017. Additional information (02/28/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and stated the issue was not related to the instrument or reagent. When the patient samples were processed automatically from the automation line the correct results were obtained. However, during the repeat testing the operator pulled the samples and repeated them manually by front loading them. This is when the discordant results were obtained. The repeat results obtained verified the initial results from the automation line. The hsc specialist stated that the issue is consistent with sample handling or operator error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00088 |
| MDR Report Key | 6283111 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-27 |
| Date of Report | 2017-03-22 |
| Date of Event | 2017-01-03 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2015-08-06 |
| Date Added to Maude | 2017-01-27 |
| 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 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | DCN |
| Date Received | 2017-01-27 |
| Model Number | ADVIA 1800 |
| 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 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | JJE |
| Date Received | 2017-01-27 |
| Model Number | ADVIA 1800 |
| 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 | 2017-01-27 |