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 2017-05-15 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[75409819]
The customer contacted a siemens customer care center (ccc) and stated that a clotted patient sample resulted without a clot error on the advia chemistry xpt instrument. The customer reviewed the instrument data and determined that there were clot d errors associated with two other patient samples run ten minutes prior to the sample in question. These samples were initially run on an alternate advia chemistry instrument and then repeated on this instrument (s/n: (b)(4)), resulting the same. The customer also stated that other samples aspirated around the same time as the sample in question had resulted acceptable. A siemens headquarters support center (hsc) specialist reviewed the information and stated that the customer has an ongoing issue with all four of their advia chemistry instruments. The hsc specialist suspects water quality as the cause of the issue, however, there is an action plan to check the alignments and function of the clot detector. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[75409820]
A discordant, falsely low total bilirubin_2 (tbil_2) result was obtained on one patient sample on an advia chemistry xpt instrument. The discordant result was not reported to the physician(s). The sample was repeated on an alternate advia chemistry xpt instrument, resulting higher. The result obtained on the alternate advia chemistry xpt instrument was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low tbil_2 result.
Patient Sequence No: 1, Text Type: D, B5
[76647673]
The initial mdr 2432235-2017-00313 was filed on may 15, 2017. Additional information (04/18/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and stated that there was no method or reagent issue. The investigation showed that clot d errors have been observed across all four advia chemistry xpt systems. The probe alignments were acceptable. Samples were reviewed and clots were visible in the specimens that received clot d errors. The hsc specialist also stated that when the system receives clot d errors and if there is an actual clot in the sample, it means that the system is performing as expected. Advia chemistry xpt s/n: (b)(4) was receiving clot c errors. A siemens customer service engineer was dispatched to the customer site on april 18, 2017 for an unrelated issue. After analyzing the instrument, the cse replaced the saline check valve and clot detection board and the clot c issue on the advia chemistry xpt s/n: (b)(4) system resolved. The hsc specialist concluded that the cause of the clot c error issue was due to the malfunction of a saline check valve and clot detection board. The device is performing within manufacturing specifications. No further evaluation of device is required. Corrected information (05/19/2017): the initial mdr indicate that the "date of event" and "date received by manufacturer" is (b)(6) 2017. The correct date is (b)(6) 2017. Updated with this information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00313 |
| MDR Report Key | 6567620 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-15 |
| Date of Report | 2018-07-11 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2017-05-15 |
| 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 | SHWETA GULATI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242870 |
| 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 | MQM |
| Date Received | 2017-05-15 |
| Model Number | ADVIA CHEMISTRY XPT |
| 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 CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-15 |
| Model Number | ADVIA CHEMISTRY XPT |
| 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 | 2017-05-15 |