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 2017-03-21 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[70519323]
The customer contacted a siemens customer care center. The customer stated that their quality controls were acceptable on the day discordant results were obtained. A siemens customer service engineer was dispatched to the customer site. After evaluating the instrument, the cse verified alignments of all the probes, calibrated cuvette temperature and replaced and aligned the photometer lamp. The customer ran quality controls, which were acceptable. The cause of the discordant, falsely elevated ldi results on three patient samples is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[70519324]
Discordant, falsely elevated lactate dehydrogenase (ldi) results were obtained on three patient samples. The initial result only for sample id (b)(6) was reported for the physician(s), who questioned it. The samples were repeated on the same instrument, resulting lower and matching the clinical picture of the patients. The corrected result was reported for sample id (b)(6) and the repeat results were reported for sample ids (b)(6). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ldi results.
Patient Sequence No: 1, Text Type: D, B5
[75240327]
The initial mdr 2517506-2017-00292 was filed on march 21, 2017. Additional information (04/13/2017): a siemens headquarters support center (hsc) specialist reviewed the instrument data, which was consistent with a sample specific issue. The instrument data indicated acceptable precision of system check parameters, precision and calibrator recovery for calibration, and quality control recovery. No error codes were recorded. The instrument data also indicated that the source lamp wavelength measurements had trended down and were below the recommended ranges. This was resolved by the siemens customer service engineer, while he was at the customer site. The hsc specialist stated that the issue with the source lamp would not cause the discordant results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00292 |
| MDR Report Key | 6423210 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-21 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-04-13 |
| Device Manufacturer Date | 2013-11-25 |
| Date Added to Maude | 2017-03-21 |
| 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 WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFH |
| Date Received | 2017-03-21 |
| 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 | 2017-03-21 |
| 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 | 2017-03-21 |