MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-05 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[18851453]
A discordant, falsely elevated acetaminophen (actm) result was obtained on one patient sample on a dimension exl with lm instrument. The discordant result was reported to the physician(s), who questioned the result. The patient was redrawn and the new sample was run on the same instrument and resulted lower. The customer replaced a reagent cartridge and then reran the samples, both of which resulted lower than the initial result. The corrected results were reported to the physician(s). There were no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated actm result.
Patient Sequence No: 1, Text Type: D, B5
[19213516]
The customer contacted the siemens technical solutions center (tsc). After evaluation of the instrument data, the tsc specialist did not find an instrument malfunction. The redraw sample had resulted as expected prior to replacement of the reagent cartridge and both samples resulted as expected prior to the tsc evaluation. The cause of the discordant, falsely elevated actm result on the initial sample from one patient sample 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 | 1226181-2013-00303 |
| MDR Report Key | 3208080 |
| Report Source | 05,06 |
| Date Received | 2013-07-05 |
| Date of Report | 2013-06-08 |
| Date of Event | 2013-06-08 |
| Date Mfgr Received | 2013-06-08 |
| Device Manufacturer Date | 2011-12-02 |
| Date Added to Maude | 2013-09-27 |
| 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 AVENUE |
| 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 WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LDP |
| Date Received | 2013-07-05 |
| Model Number | DIMENSION EXL WITH LM |
| 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 | 2013-07-05 |