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 2017-10-04 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[88233203]
The customer contacted a siemens customer care center and stated that the error result obtained on the day of the issue could not be located. Quality controls before and after running affected patient sample was within acceptable range. Due to the low volume available the sample was poured off into a small sample container cup which was inserted to the original tube for analysis on the system. All four results for tbil_2 were analyzed in the similar manner. The customer inspected the sample visually after the first result with k flag, which was found to be free of fibrin, hemolysis and bubbles. The customer did not run serum indices test on the system. The sample was front loaded on the sample turntable of the system. The customer was advised to check the sample tubes and cups for sufficient sample volume and reagent container for foam or bubbles. Quality controls were acceptable for other assays. The customer is monitoring the performance of tbil_2. There are no reports of additional discordant results. The cause of the discordant, falsely low tbil_2 result on one patient sample is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[88233204]
A discordant, falsely low total bilirubin_2 (tbil_2) result was obtained on one patient sample upon automatic repeat testing on an advia chemistry xpt instrument. The sample was initially run on the same instrument, resulting as an error with a k flag, indicating that the maximum absorbance limit was exceeded. The discordant result was reported to the physician(s), who questioned it. The sample was repeated twice on the same instrument, resulting higher both times. The corrected results were 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
| Report Number | 2432235-2017-00544 |
| MDR Report Key | 6914484 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-04 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-10-06 |
| Device Manufacturer Date | 2015-07-03 |
| Date Added to Maude | 2017-10-04 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| 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 | 2017-10-04 |
| 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 | 2017-10-04 |
| 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 | 2017-10-04 |