MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-18 for DIMENSION XPAND WITH HM manufactured by Siemens Healthcare Diagnostics.
[4419486]
A discordant, false negative low volume human chorionic gonadotropin (lhcg) result was obtained on one patient sample on a dimension xpand with hm instrument. The discordant result was reported to the physician(s), who questioned it. The sample was rerun on the same instrument and resulted higher. The corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, false negative lhcg result.
Patient Sequence No: 1, Text Type: D, B5
[11861343]
The siemens customer care center (ccc) was contacted by the customer. The ccc evaluated the instrument data and after evaluation, instructed the customer to replace and align the sample probe. The ccc also instructed the customer to run precision and determined that the chrome reading was higher on the erroneous result which is consistent with a sample integrity issue. The ccc determined that there was no instrument malfunction during the time of the event. The cause of the discordant lhcg result is unknown. The customer successfully ran qc. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00214 |
| MDR Report Key | 3760082 |
| Report Source | 05,06 |
| Date Received | 2014-04-18 |
| Date of Report | 2014-03-24 |
| Date of Event | 2014-03-20 |
| Date Mfgr Received | 2014-03-24 |
| Device Manufacturer Date | 2002-11-12 |
| Date Added to Maude | 2014-06-09 |
| 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 | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| 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 XPAND WITH HM |
| Generic Name | CLINICAL CHEMISTRY SYSTEM |
| Product Code | LCX |
| Date Received | 2014-04-18 |
| Model Number | DIMENSION XPAND WITH HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-18 |