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 2017-09-06 for DIMENSION? DF78 SMN 10444943 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[85102762]
The customer contacted siemens healthcare diagnostics questioning a discordant low valp result versus a prior higher patient recovery. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[85102763]
A discordant depressed valproic acid (valp) result was obtained on a patient sample on the dimension exl system. The result was reported to the physician who questioned the result. There are no known reports of patient intervention or adverse health consequences due to the discordant depressed valp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00686 |
| MDR Report Key | 6845712 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-06 |
| Date of Report | 2017-11-13 |
| Date of Event | 2017-08-14 |
| Date Mfgr Received | 2017-10-19 |
| Device Manufacturer Date | 2017-03-07 |
| Date Added to Maude | 2017-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? VALP VALPROIC ACID FLEX? REAGENT CARTRIDGE |
| Product Code | LEG |
| Date Received | 2017-09-06 |
| Catalog Number | DF78 SMN 10444943 |
| Lot Number | BB8066 |
| Device Expiration Date | 2018-03-07 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-06 |