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 2017-08-04 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[81961176]
The customer contacted the siemens customer care center (ccc). A siemens customer service engineer (cse) was dispatched to the customer's site. The cse performed a total maintenance service and checked cuvette temperature for accuracy and calibrated it. The cse performed alignments of reagent probe 1 (r1), reagent probe 2 (r2), reagent probe 3 (r3), sample probe and heterogeneous module pump (hm). The cse repositioned r2 drain and cuvette, and ensured r2 tubing was correctly placed. The cse calibrated r3 drain. The cse ran system check, which passed. The cse ran quality controls (qc) for total bilirubin (tbil) / direct bilirubin (dbil), resulting within specifications. Then the cse ran problem patient samples and the results were below the assay range. At the follow up visit the following day, the cse fixed the tbil low range issue by performing preventive maintenance on the instrument, after which the customer indicated tbil was in range post calibration and qc. The cause of the discordant, falsely low tbil result 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
[81961177]
A discordant, falsely low total bilirubin (tbil) result was obtained on a patient sample on a dimension exl with lm instrument. The discordant result was reported to the physician(s) who questioned it. The sample was repeated on an alternate dimension exl instrument, resulting higher. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low tbil result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00604 |
| MDR Report Key | 6767433 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-04 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-07-10 |
| Device Manufacturer Date | 2016-05-09 |
| Date Added to Maude | 2017-08-04 |
| 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 | MS. 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 | DIMENSION EXL WITH LM |
| Product Code | MQM |
| Date Received | 2017-08-04 |
| 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 | 500 GBC DRIVE P.O. BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION EXL WITH LM |
| Generic Name | DIMENSION EXL WITH LM |
| Product Code | JJE |
| Date Received | 2017-08-04 |
| 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 | 500 GBC DRIVE P.O. BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-04 |