MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-22 for DIMENSION RXL MAX WITH HM manufactured by Siemens Healthcare Diagnostics Inc..
[73515960]
A siemens customer service engineer (cse) was dispatched to the customer's site. The cse performed decontamination on the instrument. The customer has not experienced any further issues. The cause of the discordant, falsely elevated total bilirubin results 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
[73515961]
Discordant, falsely elevated total bilirubin results were obtained on four patient samples on a dimension rxl max with hm (serial number: (b)(4)) instrument. The initial results were not reported out to the physician(s). The customer repeated the same sample on another dimension rxl max with hm (serial number: (b)(4)) instrument. The customer found a positive bias with the second instrument's results. The customer reported the initial results. 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 | 2517506-2017-00423 |
| MDR Report Key | 6514109 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-22 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-03-15 |
| Date Mfgr Received | 2017-03-27 |
| Date Added to Maude | 2017-04-22 |
| 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 RXL MAX WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MQM |
| Date Received | 2017-04-22 |
| Model Number | DIMENSION RXL MAX WITH HM |
| 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 PO BOX 6101 NEWARK DE 19714 US 19714 |
| Brand Name | DIMENSION RXL MAX WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-22 |
| Model Number | DIMENSION RXL MAX WITH HM |
| 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 PO BOX 6101 NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-22 |