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 2017-04-14 for DIMENSION VISTA? 1500 SYSTEM DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics.
[72886483]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site. The cse analyzed the instrument and replaced the s1 belt, the s2 belt, probes and a vertical motor. Verification of tbil recovery by running 400 complete metabolic panels (cmp) with repeats on any tbil over 0. 8 from the aliquot plate. All results are well within manufactures specification. The instrument is performing according to specifications. The cause of the discordant tbil results is unknown. No further action required. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[72886484]
The customer stated that at least 70 discrepant, falsely elevated total bilirubin (tbil) results were obtained on a dimension vista 1500 instrument. The initial results were reported to the physician. The physician did not question the results. The tests were repeated on an alternate dimension vista 1500 and the results were lower. The repeated results were reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00371 |
| MDR Report Key | 6494183 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-14 |
| Date of Event | 2017-03-25 |
| Date Mfgr Received | 2017-03-25 |
| Device Manufacturer Date | 2008-09-24 |
| Date Added to Maude | 2017-04-14 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | REGISTRATION #: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD 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 VISTA? 1500 SYSTEM |
| Generic Name | DIMENSION VISTA 1500 |
| Product Code | MQM |
| Date Received | 2017-04-14 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA? 1500 SYSTEM |
| Generic Name | DIMENSION VISTA 1500 |
| Product Code | JJE |
| Date Received | 2017-04-14 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-14 |