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 2017-03-29 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc..
[71218499]
The cause of the discordant, falsely elevated phno result on one patient sample is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[71218500]
A discordant falsely elevated phenobarbital (phno) result was obtained on one patient sample when run in duplicate on a dimension exl 200 instrument. The sample was initially tested in duplicate and the first replicate result was higher, while the second replicate result was lower. The sample was repeated on the same instrument, resulting lower than the first replicate and higher than the second replicate of initial run. The result obtained from the repeat run was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated phno result.
Patient Sequence No: 1, Text Type: D, B5
[75755061]
The initial mdr 2517506-2017-00320 was filed on (b)(6) 2017. Additional information (04/27/2017): a siemens headquarters support center (hsc) specialist reviewed the photometric reaction data and determined that the photometric reaction for the elevated phenobarbital (phno) result was different than the second and third replicates. The customer runs all phno in duplicate, so the first 2 results for sample in question were from the same tube and the third replicate was run on the same analyzer with a different tube being reintroduced. Additionally, the filter data indicated that the 700 check was depressed and change in reaction occurred after the sample addition and mixing, based on the photometric readings. Reagent 1 was consistent and there was no drastic change after the reagent 2 addition and mixing. The hsc specialist concluded that the issue occurred at the sample addition and mixing stage. The 700 check did not show foaming and was lower than typical which would indicate an abnormal sample addition or under mixing. The hsc specialist recommended the customer to follow proper tube manufacturing instructions. The cause of the discordant, falsely elevated phno result on one patient sample was due to the sample addition and/or sample mixing issue. The instrument is performing within manufacturing instructions. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00320 |
| MDR Report Key | 6443691 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-29 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-04-27 |
| Device Manufacturer Date | 2012-06-28 |
| Date Added to Maude | 2017-03-29 |
| 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 AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | REGISTRATION #: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION EXL 200 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DLZ |
| Date Received | 2017-03-29 |
| Model Number | DIMENSION EXL 200 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION EXL 200 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-29 |
| Model Number | DIMENSION EXL 200 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-29 |