MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-17 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc.
[5045979]
Discordant, falsely elevated hemoglobin a1c (hb1c) results were obtained on three patient samples on a dimension exl 200 instrument. The falsely elevated results were reported to the physician(s). The samples were then repeated on the same instrument and resulted lower than the initial results. It is unknown if the repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated hb1c results.
Patient Sequence No: 1, Text Type: D, B5
[12518973]
The customer contacted a siemens customer care center (ccc) and reported that they had issues with quality control (qc) samples and imprecision on patient samples. The ccc advised customer to reset or replace and align the sample tip. A siemens field service engineer (fse) was dispatched to the customer's site and discovered that samples showed an elevated percentage for coefficient of variation (cv). The fse replaced sample tubing and checked the alignments. A new precision was run on samples and still observed elevated percentage cv. A new reagent lot was ordered as per the customer's request. The fse ran qc samples, which were still imprecise. The fse replaced and aligned reagent 2 probe, and performed calibration and ran a patient sample five times. The fse also performed probe alignments and verified that the instrument was operational. The cause of discordant, falsely elevated hb1c results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00591 |
| MDR Report Key | 4256382 |
| Report Source | 05,06 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-10-23 |
| Date of Event | 2014-10-21 |
| Date Mfgr Received | 2014-10-23 |
| Device Manufacturer Date | 2013-01-07 |
| Date Added to Maude | 2014-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 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 | PDJ |
| Date Received | 2014-11-17 |
| Model Number | DIMENSION EXL 200 |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-17 |