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 2017-03-28 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[71053208]
The customer contacted a siemens customer care center. The customer stated that their quality controls were within acceptable range. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluating the instrument, the cse found a problem with the pipetting of the reagents. The cse adjusted the reagent probe 1 under the cuvettes and the issue resolved. The cause of the discordant lipase results on two patient samples was due to an issue with the pipetting of the reagents. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[71053209]
Discordant lipase results were obtained on two patient samples upon repeat testing on an advia chemistry xpt instrument. The samples were initially tested on the same instrument, resulting lower for sample id (b)(6) and higher for sample id (b)(6). The discordant results were not reported to the physician(s). The samples were tested on an alternate advia chemistry xpt instrument matching the initial results obtained on the original instrument (s/n: (b)(4)). The repeat results obtained on the alternate advia chemistry instrument were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant lipase results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00224 |
| MDR Report Key | 6439618 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-03-03 |
| Date Mfgr Received | 2017-03-03 |
| Device Manufacturer Date | 2015-09-11 |
| Date Added to Maude | 2017-03-28 |
| 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 NUMBER:3003637681 3-1-2 MUSASHINO AKISHIMA |
| 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 CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHI |
| Date Received | 2017-03-28 |
| Model Number | ADVIA CHEMISTRY XPT |
| 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 CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-28 |
| Model Number | ADVIA CHEMISTRY XPT |
| 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 | 2017-03-28 |