MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-04-13 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[72810220]
The customer contacted a siemens customer care center (ccc) and stated that their level 1 quality control for ldi was out of range. The customer performed calibration and repeated quality control, which was acceptable. After quality control was within range, the customer repeated the patient sample, which resulted different from the initial result. The ccc specialist dialed into the system remotely and performed photometer arm alignment and mili amplifier unit offset calibration. The cause of the discordant, falsely low ldi result on one patient sample and level 1 quality control being out of range is unknown. The instrument is performing within specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[72810221]
A discordant, falsely low lactate dehydrogenase (ldi) result was obtained on one patient sample on a dimension exl with lm instrument. The discordant result was reported to the physician(s). 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 known reports of patient intervention or adverse health consequence due to the discordant, falsely low ldi result.
Patient Sequence No: 1, Text Type: D, B5
[77955885]
The initial mdr 2517506-2017-00392 was filed on april 13, 2017. Additional information (05/02/2017): a siemens customer service engineer (cse) reviewed the information provided by the customer and stated the customer had performed repeat testing for the sample in question after refrigerating it. The dimension lactate dehydrogenase (ldi) instructions for use under the section of specimen collection and handling states, "separated serum/plasma samples are stable for 3 days at 20 - 25? C. Do not refrigerate or freeze". For ldi assay, the results increase if the samples are refrigerated. Based on a siemens customer service specialist's observations, the repeat results are considered incorrect. The issue was resolved by calibrating temperatures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00392 |
| MDR Report Key | 6490928 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-13 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-03-22 |
| Date Mfgr Received | 2017-06-06 |
| Device Manufacturer Date | 2014-12-20 |
| Date Added to Maude | 2017-04-13 |
| 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 | 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 WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFH |
| Date Received | 2017-04-13 |
| Model Number | DIMENSION EXL WITH LM |
| 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 WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-13 |
| Model Number | DIMENSION EXL WITH LM |
| 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 | 2017-04-13 |