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 2017-07-25 for DIMENSION? DIMENSION EXL WITH LM SMN 10472176 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[80934875]
The cause for the discordant depressed actm result is instrument malfunction. A siemens customer service engineer was dispatched to the site and performed service including maintenance on the optical system. They also checked cuvette manufacturing, cleaned drains, and checked syringes. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[80934876]
A discordant falsely depressed acetaminophen (actm) result was obtained on the dimension exl instrument. The result was flagged below assay range and was not reported to the physician. The same sample was repeated on the same instrument and on an alternate dimension exl instrument and a higher result was obtained and reported. There are no known reports of patient intervention or adverse health consequences due to the discordant depressed actm result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00605 |
| MDR Report Key | 6739668 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2011-11-21 |
| Date Added to Maude | 2017-07-25 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| 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? |
| Generic Name | DIMENSION? EXL WITH LM INTEGRATED CHEMISTRY SYSTEM |
| Product Code | LDP |
| Date Received | 2017-07-25 |
| Model Number | DIMENSION EXL WITH LM |
| Catalog Number | SMN 10472176 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? EXL WITH LM INTEGRATED CHEMISTRY SYSTEM |
| Product Code | JJE |
| Date Received | 2017-07-25 |
| Model Number | DIMENSION EXL WITH LM |
| Catalog Number | SMN 10472176 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |