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 2016-08-25 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc.
[53004686]
The customer contacted the siemens customer care center (ccc). The customer provided quality controls (qc) data of runs prior to and after the discordant results, and results were within range. The customer declined any troubleshooting of the instrument. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[53004687]
Discordant, falsely elevated gentamicin results were obtained upon initial and repeat testing on one patient sample on a dimension vista 1500 instrument. The discordant result obtained after repeat testing was reported to the physician(s), who questioned it. The sample was repeated multiple times on the same instrument, resulting lower. 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 elevated gentamicin results.
Patient Sequence No: 1, Text Type: D, B5
[58046214]
The initial mdr 1226181-2016-00414 was filed on august 25, 2016. Additional information (09/15/2016): a siemens headquarter support center (hsc) reviewed the instrument data. There were no result flags or process errors reported. Result monitors were normal and matched the repeat samples. Prior to the event, the customer had ran a (b)(6) study on another method. The linearity study uses "drug 2" calibrator which has a concentration of gentamicin of around 12 ug/ml. The (b)(6) study was cancelled while processing, but it had already sampled the calibrators. The calibrator was the prior sample sampled prior to the gentamicin result which recovered high. The customer stated that they ran an acid clean, but hsc could not rule out the possibility that there was carryover from the "drug 2" calibrator. The customer did not provide additional information in reference to pre-analytical handling of the specimen. The cause of discordant, falsely elevated gentamicin result on patient sample 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
| Report Number | 1226181-2016-00414 |
| MDR Report Key | 5904134 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-25 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-09-15 |
| Device Manufacturer Date | 2009-06-24 |
| Date Added to Maude | 2016-08-25 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10594 |
| Manufacturer Country | US |
| Manufacturer Postal | 10594 |
| Manufacturer Phone | 9145243105 |
| 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 VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LCD |
| Date Received | 2016-08-25 |
| Model Number | DIMENSION VISTA 1500 |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-08-25 |
| Model Number | DIMENSION VISTA 1500 |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-25 |