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 2017-03-28 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[71099037]
The customer contacted a siemens customer care center (ccc) specialist. The customer ran quality control (qc), resulting out of range. The customer bumped into a new well, still resulting out of range. The customer used a new flex and a fresh level 3 qc, resulting within range. The customer ran qc level 1, resulting within range. The ccc reviewed the reagent probes, resulting within specifications. The ccc reviewed the system check, resulting within range. The ccc performed troubleshooting with the customer. The customer primed reagent probe 2 and reagent probe 3, and did not find any issues. The customer reseated the probes and performed alignment. The customer ran a precision study for blood urea nitrogen, resulting within range. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[71099038]
Discordant, falsely depressed blood urea nitrogen results were obtained on seven patient samples on a dimension exl with lm instrument. The initial results were reported out to the physician(s). The customer reviewed their instrument data and found their quality control (qc) was out of range. The customer repeated the same samples on the same dimension exl with lm instrument, resulting higher. The customer issued corrected reports to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed blood urea nitrogen results.
Patient Sequence No: 1, Text Type: D, B5
[75944311]
The initial mdr 2517506-2017-00302 was filed on march 28, 2017. Additional information (04/20/2017): the siemens headquarters support center (hsc) reviewed the event. Hsc found result monitor a was above the upper limit. Result monitor appears to have enough results to flag abnormal assay, but no tests flagged as they should. Hsc found that the result monitor was turned off. The customer turned the result monitor back on. Had the result monitor been on, all results from the suspect well set would have flagged with "abnormal assay" and been non-reportable results. Hsc stated the issue was a hydration issue of the specific well set. After the customer reseated and realigned reagent 2 and reagent 3 probes, there have not been any further issues. The cause of the discordant, falsely depressed blood urea nitrogen results is due to a hydration issue of the specific well set. 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 | 2517506-2017-00302 |
| MDR Report Key | 6441700 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-28 |
| Date of Report | 2017-05-15 |
| Date of Event | 2017-02-28 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2009-05-27 |
| Date Added to Maude | 2017-03-28 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | REGISTRATION NUMBER: 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 | CDQ |
| Date Received | 2017-03-28 |
| 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 19714 US 19714 |
| Brand Name | DIMENSION EXL WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-28 |
| 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 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-28 |