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 2016-05-26 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc.
[45973892]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated that they performed calibration. Upon the ccc specialist's recommendations, the customer performed precision testing, which were acceptable. Upon the customer's request, the ccc specialist dispatched a siemens customer service engineer (cse) specialist to the customer site. After evaluating the instrument, the cse checked the photometer lamp and replaced and aligned it. The cse replaced the sample probe tip and trimmed the sample tubing end that had a kink. The cse ran a system check and quality controls and performed precision testing, all of which were acceptable. The cause of the discordant calcium results on five patient samples 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
[45973893]
The operator of a dimension exl with lm instrument stated that the initial and repeat results for five patient samples tested for calcium did not match. The initial results were lower than the repeat results. The initial and repeat results were not reported to the physician(s). Troubleshooting was performed on the instrument and the samples were repeated again on the same instrument. The repeat results obtained after troubleshooting were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant calcium results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2016-00294 |
| MDR Report Key | 5681510 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-26 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-05-02 |
| Device Manufacturer Date | 2015-05-26 |
| Date Added to Maude | 2016-05-26 |
| 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 | 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 WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CIA |
| Date Received | 2016-05-26 |
| Model Number | DIMENSION EXL WITH LM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| 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 | 2016-05-26 |