MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-17 for DIMENSION RXL MAX WITH HM manufactured by Siemens Healthcare Diagnostics Inc.
[5018911]
Discordant, falsely elevated hemoglobin a1c (hb1c) results were obtained on multiple patient samples on a dimension rxl max with hm instrument. The discordant results were reported to the physician(s) who questioned them. The samples were repeated on the same instrument. The corrected hb1c results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant hb1c patient results.
Patient Sequence No: 1, Text Type: D, B5
[12517533]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and instrument data and replaced the reagent 2 and reagent 3 transducer, heat torch and lamp. The cse checked alignments and cleaned windows. The cause of the discordant hb1c results is unknown. The cse successfully ran quality controls. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00593 |
| MDR Report Key | 4256883 |
| Report Source | 05,06 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-10-23 |
| Date of Event | 2014-10-22 |
| Date Mfgr Received | 2014-10-23 |
| Device Manufacturer Date | 2007-12-03 |
| Date Added to Maude | 2014-11-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| 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 RXL MAX WITH HM |
| Generic Name | CLINICAL CHEMSITRY SYSTEM |
| Product Code | PDJ |
| Date Received | 2014-11-17 |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-17 |