MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-06 for DCA VANTAGE ANALYZER 10282969 manufactured by Simens Healthcare Diagnostics Inc..
[4210472]
Customer reported discordant hemoglobin alc (hba1c) results on the instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[11654433]
The causse for the discordant hemoglobin alc (hba1c) is unknown. Additional information has been requested by the siemens representative but the customer has not provided any additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2014-00009 |
| MDR Report Key | 3628076 |
| Report Source | 07 |
| Date Received | 2014-02-06 |
| Date of Report | 2014-01-28 |
| Date of Event | 2014-01-24 |
| Date Mfgr Received | 2014-01-28 |
| Date Added to Maude | 2014-03-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE ANDBERG |
| Manufacturer Street | 2 EDGEWATER DR. |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | NORTHERN RD. CHILTON INDUSTRIAL ESTATE |
| Manufacturer City | SUDBURY, SUFFOLK CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DCA VANTAGE ANALYZER |
| Product Code | PDJ |
| Date Received | 2014-02-06 |
| Catalog Number | 10282969 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-06 |