MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-14 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc.
[4989360]
Discordant, falsely elevated hemoglobin a1c (hb1c) results were obtained on one patient sample on a dimension exl 200 instrument. The initial discordant result was reported to the physician(s). The sample was repeated on the same instrument with a new flex reagent, resulting without change. The sample was then repeated on an alternate instrument, resulting lower. The corrected result was 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
[12555919]
The customer contacted the siemens customer care center (ccc). The cause of the discordant, falsely elevated hb1c results is unknown. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[32638639]
The initial mdr 1226181-2014-00580 was filed on november 14, 2014. Additional information/ correction (10/21/14): a siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse replaced the reagent probe 1 tubing due to a pin hole, primed the system, and ran a system check. Quality controls were run, resulting within range. The cause of the 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 | 1226181-2014-00580 |
| MDR Report Key | 4251890 |
| Report Source | 05,06 |
| Date Received | 2014-11-14 |
| Date of Report | 2014-10-20 |
| Date of Event | 2014-10-20 |
| Date Mfgr Received | 2014-10-21 |
| Device Manufacturer Date | 2012-01-10 |
| Date Added to Maude | 2014-11-26 |
| 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 | 0 |
| 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 | 2014-11-14 |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-14 |